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LEVOFLOX: Armed with Excellence

Qui nolones are a very i mportant family of anti bacteri al agents that are w i del y prescri bed for the treatment of i nfections i n humans. Si nce thei r discovery i n the earl y 1960s, the qui nol one group of anti bacteri al s has generated consi derabl e cli ni cal and sci enti fic interest.

Levofl oxaci n i s a syntheti c chemotherapeuti c anti biotic of the qui nolone drug cl ass and i s used to treat severe or l ife-threateni ng bacteri al infections or bacteri al i nfecti ons that have failed to respond to other anti bioti c cl asses. It i s a trusted and accepted mol ecul e for treati ng vari ous respi ratory tract as well as uri nary tract i nfecti ons. Recentl y, a hi gh-dose, short-course regi men (750 mg once dail y for 5 days) of l evofloxaci n has been devel oped with the ai m of enhanci ng concentration-dependent bacteri ci dal acti vity and reduci ng the potenti al for the emergence of resi stance. The c onveni ent once-daily dosi ng is of parti cul ar benefi t i n those pati ents w ho may not be compli ant. Levofloxaci n is rapi dly bacteri cidal and has a broad spectrum of acti vity, with a better safety and tol erabi lity profi le compared to other qui nol ones. Excell ent bioavail abil ity wi th both orall y and i ntravenousl y avail abl e forms advances i ts use for treati ng various di ffi cul t-to-treat i nfecti ons.

Levofl oxaci n i s one of the respi ratory fluoroqui nolones that i s recommended by i nternati onal gui del i nes li ke IDSA, ATS and ERS for treati ng various respi ratory tract i nfections. The mol ecul e, due to i ts excell ent tissue concentrati ons i n the uri nary tract, i s al so recommended by the European Associ ati on of Urology (EAU) for treati ng vari ous complicated and uncomplicated uri nary tract i nfecti ons. Levofloxaci n is approved for treati ng nosocomial and communi tyacqui red pneumoni a, acute bacteri al si nusitis, acute bacteri al exacerbati on of chroni c bronchi ti s, complicated/uncomplicated ski n and ski n structure i nfections, chroni c bacteri al prostati ti s, compl icated/uncomplicated uri nary tract i nfecti ons, acute pyel onephri tis, and i nhal ational anthrax (post-exposure).

LEVOFLOX (Levofl oxaci n) is currentl y avai l abl e as 250 mg , 500 mg and 750 mg oral tabl ets, and a 500 mg i ntravenous (I.V.) i nfusion. The usual dose of l evofloxaci n tabl ets i s one tabl et every 24 hours, w hil e the I.V. solution i s to be admi nistered by sl ow i nfusi on over 60 mi nutes every 24 hours.

May 2011

Top Cefoprox CV: The extra whenever you need

The most i mportant concern i n the management of upper respi ratory tract i nfecti ons (URTIs) i s Anti biotic resi stance.

Worl dwi de evi dence suggests that i nappropri ate anti bioti c use for non-severe URTIs, most of which are vi ral, adds to the overall burden of anti biotic resi stance, a phenomenon whi ch i s becomi ng more preval ent. Thi s resistance to anti biotics consti tutes a major threat to publi c heal th. Nowadays, the resi stance pattern for Cefpodoxi me i n Indi a for vari ous pathogens i s on the i ncreasi ng trend such as for E.coli (85%), K. pneumoniae (65%), S. aureus (60%), P. aerugi nosa (100%), A. baumanni i (67%) etc.

Therefore rei ntroduction of currentl y avai l abl e peni cilli ns and cephal ospori ns along with other agents such as -l actamase i nhi bitors i s an attracti ve opportuni ty for many reasons: Wel l established safety and effi cacy profil e, Producti on of -l actamase i s the most common mechani sm of resistance to l actam anti bioti cs, especi all y i n gram negati ve bacteri a, Conveni ence of use, and more essenti al ly an understandi ng that usi ng such combi nati on empi rically may hel p in not onl y overcome therapeuti c failures due to resistant bacteri a but will al so del ay resistance devel opment i n suscepti bl e bacteri a.

Hence the combi nati on of Cefpodoxime (3

rd

generati on cephal osporin) and

Cl avul ani c acid (-l actamase i nhi bitor) provides a sol ution for treatment of bacteri al i nfecti ons caused by beta l actam resi stant pathogens.

CEFOPROX CV i s a combi nation of a thi rd generati on -l actam anti bioti c Cefpodoxi me proxeti l 200 mg al ong wi th a -lactamase i nhi bitor Cl avul ani c aci d 125 mg.

DO SAGE AN D IND ICATION S

Adults and Adolescents (aged 12 years an d older) Type of i nfections Total daily dose Pharyngi ti s and/or tonsilliti s 200 mg Dose frequency 100 mg q12 hours 5-10 days Durati on

Acute communi tyacqui red pneumoni a Acute bacteri al exacerb ati ons of chroni c bronchi ti s Ski n and ski n structure Acute maxil lary si nusi ti s Uncomplicated uri nary tract i nfecti on

400 mg

200 mg q12 hours

14 days

400 mg

200 mg q12 hours

10 days

800 mg

400 mg q12 hours

7-14 days

400 mg

200 mg q12 hours

10 days

200 mg

100 mg q12 hours

7 days

*Dose of CEFOPROX CV Tabl ets i s based on the cefpodoxi me component.

KEY HIGHLIG HTS

1.

More potent in vitro activi ty i n compari son to amoxi cilli n+ cl avul ani c aci d agai nst -lactamase produci ng strai ns of Gram-posi tive and Gramnegati ve bacteri a.

2.

8-fold reducti on in MIC agai nst ESBL-posi tive organi sm has been observed. The combi nati on extends the anti bioti c spectrum and enhances the acti vity of cefpodoxi me.

3.

4.

Hi ghl y effective combi nation i n Swi tch Therapy.

Apri l 2011

Top Montair FX: For an Active, Non-Sedative Day i n AR

All ergic Rhi niti s (AR) is a common di sease worl dwide, affecti ng about 1050% of the popul ati on. I t exacts a toll on a pati ent's quality of li fe, cogni tive and l earni ng functions, deci sion-maki ng and sel f-percepti on and, if l eft untreated, can contri bute to co-morbiditi es, i ncl udi ng asthma, si nusi tis and otiti s medi a

wi th effusion or the devel opment of nasal pol yps.

MON TAIR FX is a combi nation of an antil eukotri ene montel ukast 10 mg wi th the second generation anti histami ne fexofenadi ne 120 mg.

Montel ukast is a sel ective and oral ly acti ve l eukotri ene receptor-antagoni st that i nhibi ts CysLT
1

wi th 24-hour acti on. It has been shown to decrease the number

of eosinophil s in the blood of pati ents wi th AR, suggesti ng a decrease i n the i nfl ammation and i mprovement i n dayti me and ni ght-ti me symptoms as w el l as to i mprove the di sease-rel ated qual ity of l ife.

Fexofenadi ne hydrochl ori de, a second-generati on anti hi stami ne, is the pharmacol ogical metabolite of terfenadi ne and a potent and sel ecti ve antagoni st of peri pheral H 1 -receptors. It has an earl y onset of acti on as compared to l evoceti rizi ne, and causes a si gni ficantl y hi gher reducti on in the wheal size after 3 to 6 hours w hen compared to desl oratadi ne. Fexofenadi ne i s as effecti ve as the popul ar anti hi stami ne, cetiri zi ne, but i t l acks the sedati ng effects associ ated wi th ceti ri zi ne. Thi s is because of its i nabil ity to cross the bl oodbrai n barri er. Fexofenadi ne is al so superi or to loratadi ne i n i mprovi ng nasal congestion, ocul ar symptoms and the qual ity of life for pati ents with AR.

The combi nati on of montel ukast and fexofenadi ne has been shown to be superior to monotherapy i n a randomi zed, doubl e-blind, mul ticentred, prospecti ve study wi th 275 ad ul t pati ents in terms of reducti on i n nasal obstruction, nasal resi stance as well as i n dail y symptoms and al so offered higher pati ent sati sfacti on.

Thus wi th the i ntroduction of MON TAIR FX , there opens up another treatment opti on for pati ents wi th AR w ho w ant complete control al ong wi th no sedati on.

March 2011

Top ROK FOS: Infusing life into Bones

Osteoporosi s is a progressi ve systemi c disease resul ti ng i n i ncreased bone fragil ity and suscepti bility to fractures at vertebral and nonvertebral sites.

Therapeuti c adherence i s a key factor i nfl uenci ng the effecti veness of treatment i n chroni c diseases where the effects of the therapy can o nl y be seen after a

long-term applicati on of drugs or are subj ecti vel y not percei ved at all .

The si tuation is even more complicated i n chroni c asymptomati c di seases l ike hypertensi on or osteoporosis.

Once yearl y dosi ng with Zoledroni c aci d is a new al ternati ve i n the therapy of osteoporosis and represents an i mportant step towards an i mprovement i n the adherence to treatment.

Ci pl a i ntroduces RO KFOS , once yearl y Zoledroni c aci d 5 mg for the manag ement of osteoporosis.

RO KFOS is i ndi cated for:

y y y y

Treatment and Preventi on of post-menopausal osteoporosis. of postmenopausal osteoporosi s Treatment to i ncrease bone mass i n men wi th osteoporosis. Treatment of Paget's di sease of the bone. Preventi on & treatment of glucocorticoi d i nduced osteoporosi s.

The recommended dose i s a singl e i ntravenous i nfusion of 5 mg Zol edroni c aci d admi nistered once a year gi ven over no less than 15 mi nutes. How ever, for preventi on of postmenopausal osteoporosis, the recommended dose i s a 5 mg i nfusi on given once every 2 years i ntravenousl y over no l ess than 15 mi nutes.

March 2011

Top VA NLID 250: Hands down Vi ctory against MRSA

Staphylococcus aureus ( S. aureus) i s an i mportant pathogen that frequentl y causes cl ini cal disease i n chil dren. A wide array of ill nesses can be caused by thi s common pathogen rangi ng from non-i nvasi ve ski n infecti ons to severe, lifethreateni ng sepsi s. Addi tionally, as anti bacteri al s have been used to eradi cate S. aureus , i t has devel oped resi stance to these i mportant therapeuti c agents. Growi ng bacteri al resistance means that w hat were once effecti ve and i nexpensi ve treatments for i nfecti ons caused by these bacteri a are now bei ng

seri ousl y questi oned.

Methi cilli n-resi stant S. aureus (MRSA) has become an i ncreasi ng probl em i n pedi atric pati ents over the past decade. A new type of staphyl ococcus, usually termed communi ty-acqui red MRSA (CA-MRSA), whi ch is resi stant to fewer anti biotics compared to the HA-MRSA, has al so emerged in the paedi atri c age group.

Vancomyci n was i ntroduced i n 1958 and has been a useful anti bioti c for about 50 years. The recent advent of MRSA has provi ded a renaissance for thi s gl ycopepti de. Over the years, vancomyci n has become the mai nstay of MRSA i nfecti on therapy and thus, i s the pri mary therapeuti c option i n severe, li fethreateni ng i nvasi ve MRSA i nfections.

Several l iteratures have shown vancomyci n to be clini cally and mi crobiologicall y (i ncl udi ng the resi stant Gram-posi ti ve organi sms) consi stentl y very effecti ve across al l i nfecti ons caused by presumed or documented resi stant Gram-posi tive pathogens across all paedi atri c age groups, i ncludi ng neonates. Vancomyci n is wel l-tol erated and safe i n paedi atric pati ents i ncludi ng i n the cri ti cal ly i ll neonates.

VANLID 250 is India's First vancomyci n I.V. with the ri ght strength of 250 mg for paedi atri c pati ents. VANLID 250 is a chromatographi cal ly purifi ed and lyophi lized product.

VANLID 250 is indi cated for the treatment of staphylococcal i nfecti ons like lower respi ratory tract i nfections (like pneumoni a), septi caemi a, ski n and soft ti ssue i nfecti ons and osteomyeli tis. It is al so i ndicated for treatment of endocardi tis caused by Staphyl ococci, Streptococcus viridans* or Streptococcus bovi s* and Enterococci (e.g. E.faecal is ),** and Di phtheroi ds , for the treatment of earl y-onset prostheti c val ve endocardi ti s caused by Staphylococcus epidermidis or diphtheroi ds $ and as prophyl axi sagai nst endocardi tis i n pati ents at ri sk from dental or surgi cal procedures.

In paedi atri c pati ents, the usual I.V. dosage of 10 mg/kg per dose i s recommended every 6 hours (total dail y dosage 40 mg/kg of body wei ght). In neonates and young i nfants, an i ni ti al dose of 15 mg/kg is suggested, followed by 10 mg/kg ever y 12 hours i n the fi rst week of life and every 8 hours thereafter unti l 1 month of age. Longer dosi ng i nterval s may be necessary i n premature i nfants. Each dose shoul d be admi ni stered over a peri od of at least 60 mi nutes.

Parenteral form of vancomci n can be admi ni stered oral ly for treatment of anti biotic-associ ated pseudomembranous coliti s produced by C. di ffi cil e and Staphyl ococcal enterocoli ti s.

Oral ly, VANLID 250 I.V. can be admi nistered usi ng 40 mg/kg body w ei ght in three or four di vided doses for 710 days. The total dail y dose shoul d not exceed 2 g.

Dosage adjustment must be mad e i n pati ents wi th impai red renal function.

*Vancomyci n al one or i n combination wi th an ami noglycoside **Vancomycin only i n combination w ith an aminogl ycoside $ Vancomycin in combination wi th ei ther rifampi n or an ami noglycoside or both

Top VC 15: Healthy Skin Expert

Vi tami ns such as A, C and E are natural l y present i n human ski n. These vi tami ns are part of a compl ex system of enzymati c and non-enzymati c anti oxi dants that protect the ski n from harmful reacti ve oxygen species. How ever, the ski n i s subj ected to substanti al envi ronmental free radi cal stress from sunlight, poll ution and smoki ng, all of whi ch depl ete the dermal stores of naturall y occurri ng anti oxi dants. To repl eni sh these l osses, vi tami ns shoul d be appli ed topi cally on the ski n.

Vi tami n C (L-ascorbi c aci d) is the body' s major aqueous phase antioxi dant and i s vi tal for li fe. Oral suppl ementati on with Vitami n C does li ttl e to i ncrease ski n concentrati on because acti ve transport of vitami n C from the gastroi ntesti nal tract i s li mi ted. Therefore, topi cal appli cation of vi tami n C i s the preferred method to i ncrease i ts presence i n the ski n.

Vi tami n C i s an excell ent anti oxidant that sequentiall y donates el ectrons, thereby neutrali zi ng free radi cal s present i n the aqueous compartment of the cell. Along with i ts anti oxidant property i t has al so got photoprotecti ve, depi gmenti ng and anti -infl ammatory properti es. Vitami n C al so provi des the addi tional advantages of repl eni shi ng vitami n E and sti mulati ng dermal collagen synthesi s, a major target i n chroni c photoagi ng.

VC 15 contai ns L-ascorbi c aci d at a concentration of 15%. It is a stabl e formul ati on with a pH of 2.7. VC 15 promises to be non-i rri tati ng and noncomedogeni c. It is avai l able i n a bottl e of 15 ml along wi th a dropper.

VC 15 is i ndi cated for photodamaged/ agi ng ski n, mel asma/ hyperpi gmentation,

acne and acne scars and post procedure i nfl ammation.

Properti es supporting clinical uses of topical vi tami n C (VC 15)

Clinical Uses Photodamaged/Aging skin Dry ski n

Properti es

Moi sturi zation

Dul l compl exi on, rough texture

Photoprotecti on and anti oxidant

Fine li nes and deep wri nkl es Col l agen synthesi s and Age spots anti oxidant

Depi gmentati on and photoprotecti on Melasma/hy perpigmentati on Depi gmentati on and photoprotecti on Acne and acne scars Antioxi dant, anti i nfl ammatory and collagen synthesi s Post-proc edure inflammation Antioxi dant and anti i nfl ammatory

VC 15 shoul d be used once daily i n the morni ng. With the hel p of the dropper, take 7 to 10 drops of VC 15 onto your fi ngerti ps. Then, dab the serum onto your face and neck and gentl y massage until it i s completel y absorbed.

VC 15 shoul d be used wi thi n one month after openi ng the bottl e.

Top ENTAVIR: Persistent Efficacy in Treating Chronic Hepatitis B

Chroni c hepati tis B is a worl dwi de publi c heal th chal lenge, approxi matel y 2 billion peopl e w orldwide have been i nfected by hepati ti s B vi rus, and more than 350 mi llion are chroni c carri ers.

The pri mary goal i n chroni c hepati ti s B treatment is to reduce serum HBV DNA

l evel to the l owest possi bl e level (undetectabl e) and thereby decrease the ri sk of devel opi ng li ver cirrhosis and liver cancer.

Entecavi r (ETV), a guanosi ne nucl eosi de analogue, is a potent and sel ecti ve i nhibi tor of hepati ti s B virus replicati on with around 94% p ati ents conti nui ng to remai n HBV DNA undetectabl e and 80% pati ents with normali zation of li ver enzymes at the end of 5 years of conti nuous entecavi r therapy. Entecavi r resi stance i s rare i n nucl eoside-na ve pati ents, around 1.2% after 6 years of treatment. It is recommended as a fi rst li ne treatment i n lami vudi ne-na ve chroni c hepati ti s B pati ents.

Long-term entecavi r therapy l eads to potent suppression of HBV DNA, normal ization of ALT and i mprovement i n li ver histology with accompanyi ng regressi on of fibrosis, i ncludi ng those wi th advanced fi brosis or ci rrhosi s at basel i ne. Recent studi es have shown that entecavi r has al so been successful i n preventi ng acute liver fai lure i n pati ents of acute hepati ti s B and progressi on to chroni c hepati ti s B. It can al so be safel y and effectivel y used i n HBV i nfected pati ents pre or post renal transpl ant without any renal compromi se.

ENTAVIR (entecavi r) is a fil m coated tabl et for oral use and i s avai l abl e i n two dose strengths of 0.5 mg and 1.0 mg w hi ch have speci fic indi cations i n pati ents of chroni c hepati tis B as menti oned bel ow.

ENTAVIR tabl ets are i ndi cated for the treatment of chronic hepati tis B virus i nfecti on i n adul ts(= 16 years of age ) with evi dence of acti ve vi ral repli cation and ei ther evi dence of persistent el evati ons i n serum ami notransferases (ALT or AST) or histol ogi cal ly acti ve disease.

ENTAVIR tabl ets shoul d be admi nistered on an empty stomach (at l east 2 hours after a meal and 2 hours before the next meal ).

Recommended Dosage

Compensated Liver D isease

The recommended dose of entecavi r for chroni c hepati ti s B vi rus i nfecti on i n nucl eoside treatment-na ve adul ts and adol escents 16 years of age and ol der i s 0.5 mg once dail y.

The recommended dose of entecavi r i n adul ts and adol escents (at l east 16 years of age) wi th a hi story of hepati tis B vi remi a while recei vi ng l ami vudi ne or know n l amivudi ne or telbi vudi ne resi stance mutati ons rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.

Decompensated Liver Disease

The recommended dose of entecavi r for chroni c hepati ti s B vi rus i nfecti on i n adul ts with decompensated liver disease i s 1 mg once dai ly.

Dosage adjustment i s recommended for pati ents with creati ni ne cl earance l ess

than 50 mL/mi n, i ncludi ng pati ents on hemodi alysis or conti nuous ambul atory peri toneal di al ysi s (CAPD).

The opti mal duration of treatment wi th entecavi r for pati ents with chroni c hepati ti s B virus i nfecti on and the rel ati onshi p between treatment and long-term outcomes such as ci rrhosis and hepatocel l ular carcinoma are unknown.

January 2011

Top FORACORT A UTOH ALER- Make a Smarter Choice

Foracort Autohaler i s the w orld's first breath-actuated i nhal er containi ng a combi nati on of formoterol with budesoni de.

Foracort Autohaler contai ns 6 mcg of formoterol and 200 mcg of budesoni de. Thi s combi nation is an effecti ve and conveni ent option for the mai ntenance treatment of pati ents wi th asthma i n whom dual asthma mai ntenance therapy i s warranted. The use of formoterol with budesoni de for both dail y mai ntenance therapy and as-needed reli ef of breakthrough symptoms usi ng a si ngl e i nhal er i s a new approach to asthma management and i s i ndi cated i n pati ents wi th persi stent asthma. Thi s treatment strategy si gni ficantl y reduces the rate of severe asthma exacerbati ons compared wi th the traditional approach of usi ng an i nhal ed corti costeroid wi th l ong-acti ng beta agoni st (ICS/LABA) with a shortacti ng beta agoni st (SABA) and achi eves equi val ent dail y symptom control compared wi th hi gh dose of I CS/LABA pl us separate SABA for reli ef.

Foracort is already avai l abl e as a dry powder i nhaler (DPI) i n the form of Rotacaps to be used wi th a Rotahal er or a Revol izer and as a pressuri sed metered dose i nhal er (pMDI).

The Autohal er overcomes the key probl em of the pMDI vi z. coordi nation of actuati on wi th i nhal ati on and does not rel y on the pati ent`s i nspi ratory effort to

aerosoli ze the dose of medi cati on unli ke dry powder inhal ers. Autohal er i s acti vated at low flow rates of 22-30 l/sec. Studi es have show n that the Autohaler i s easi er to use and to teach as compared to pMDIs and some of the DPIs. It can al so be used by chil dren who are wheezi ng, ol der pati ents wi th severe ai rflow obstructi on and those wi th arthri tis. Autohal er contai ns 300 doses, which ensures long term medi cati on for the pati ent, thus offers better adherence and compliance.

January 2011

Top MOXICIP KT: Where power Breeds Safety

Indi a has experi enced an exponenti al i ncrease i n the number of cataract surgeri es. An esti mated 0.5 million cataract surgeri es w ere done i n 19811982; thi s i ncreased to 4.8 million i n 2006 wi th 90% i ntraocul ar l ens acceptance. Infl ammati on has alw ays been accepted as a natural consequence of the cataract surgi cal procedures and al so these procedures are associ ated wi th a ri sk of i nfection. These consequences are general l y treated with anti i nfl ammatory (steroi ds) and anti -i nfecti ve eye drops. But the adverse consequences associ ated with l ong term use of steroids and the resi stance and effi cacy i ssues associ ated with the use of older generation anti -infecti ves warrants the need for a combi nati on w herei n Power Will Breed Safety.

MOXICIP KT contai ns Moxi floxaci n, a geneti call y smart, broad spectrum fl uoroqui nol one and Ketorol ac a potent anti -infl ammatory and anal gesi c non steroi dal anti i nflammatory. The combi nati on of these drugs has posi ti ve therapeuti c effect on postoperati ve i nflammati on and preventi on of postoperati ve i nfecti on fol lowi ng cataract surgery. Al so the presence of an anti i nfl ammatory and anti biotic agent i n a si ngl e ophthal mic product overcomes any potenti al 'w ashout effect' that may be seen when separate medi cati ons are used. In addi tion, the combi nation al so leads to better compli ance, pati ent comfort and safety. The reduced number of admi ni strati ons wi th this combi nati on may be of parti cul ar benefit for el derl y pati ents, who make up the majori ty of cataract surgery cases.

MOXICIP KT contai ns Moxi floxaci n 0.5% (anti -infecti ve) and Ketorol ac 0.5% (anti -infl ammatory non steroidal ). It is the Worl d' s fi rst anti biotic and NSAID combi nati on to be preservati ve free and wi th HEC (Hydroxyethyl cellul ose). HEC is a polymer w hi ch acts as a viscosi ty enhancer i mprovi ng the retenti on ti me of

the drug.

INDICATIONS For NSAID-responsi ve i nfl ammatory ocul ar condi ti ons for whi ch a NSAID i s i ndicated and w here bacteri al i nfection or a risk of bacteri al ocul ar infection exi sts.

The use of a combi nation drug with an anti - i nfective component i s i ndicated where the ri sk of superfi ci al ocul ar infecti on i s hi gh or where there i s an expectati on that potenti all y dangerous numbers of bacteri a will be present i n the eye.

DO SAGE AN D ADMINISTRATION One drop i n affected eye three ti mes a day

MOXICIP KT: Highli ghts

Fi rst a Combi nati on of

o o y y y y
ti me

Moxi fl oxaci n: A broad spectrum, potent, 8 methoxy fl uoroqui nol one. Ketorol ac: A potent anti i nflammatory and anal gesi c agent

A combi nati on with HEC advantage whi ch i ncreases the drug retenti on

A combi nati on with no preservati ve w hi ch resul ts in No corneal toxi city A combi nati on w hich can be used for wi de array of indicati ons A combi nati on w hich will provide Pati ent compliance and Long term usage.

Decemb er 2010

Top LACSYP: Differences Do Matter

Consti pati on affects al most everyone at one ti me or another and i s a symptom caused by vari ous factors that are not al ways di scernabl e. Consti pati on is marked by a mul ti tude of presentations, rangi ng from an inabi lity to pass stools to l ess than three stool s i n a week. Pati ents often i nclude di ffi cul ty i n passi ng

stools, hard stools, and the sensati on of i ncompl ete bowel movement as consti pati on.

Al though consti pati on is more often than not a temporary condi tion, i t affects around 30% of the popul ation at some poi nt of ti me. Very commonl y, consti pati on is caused due to li festyl e choi ces such as i nacti vi ty, low fiber, ignori ng the urge, or even dehydrati on. How ever, medicati on, surgeri es and pregnanci es are al so common causes of consti pati on. Though the symptoms associ ated with constipati on are often i ntermi ttent and mil d, they may be chroni c, difficul t to treat and debili tati ng.

Lacsy p (l acti tol) i s a second-generati on disacchari de agent used frequentl y as a l axati ve. Descri bed first i n 1979, thi s pl easant tasti ng, non-absorbabl e sugar i s used as an arti fici al sweetener i n food preparati ons. Like its anal og, l actul ose, l acti tol too is used for the treatment of hepati c encephal opathy and consti pati on. Both have been show n to be equally effi cacious; how ever, l actitol i s wi thout certai n discomforts associated with l actulose. Al though effecti ve, many pati ents are i ntolerant to l actul ose because of i ts nauseatingl y sweet taste and, qui te often, the i ntesti nal di scomfort associ ated with bloati ng and abdomi nal pai n adds an unnecessary burd en on pati ents.

The predi ctabl e catharti c effect of l acti tol, unli ke l actul ose, has made i t the clear choi ce of pati ents i n comparati ve tri als. Rapi d resoluti on of hepati c encep hal opathy, an end-stage liver disease compl ication, extends the benefi ts of thi s non-absorbabl e sugar beyond pati ent tol erability and pal atability. Bei ng non-absorbabl e, the potenti al for systemic side effects are li mited. Dosi ng with thi s agent has no effect on the bl ood sugar l evel s even i n pati ents wi th diabetes.

Lacsy p offers a sw eet and preferred opti on to manage conditi ons from as troubl esome as consti pation to serious condi tions like hepati c encephal opathy.

Decemb er 2010

Top Vertipress - Suppressing Vertigo, Balancing Li ves

Verti go or gi ddi ness i s a di sturbance of the sense of equi libri um and movements, where the person feel s that ei ther hi s surroundi ngs are goi ng round hi m or he hi mself i s rotati ng. The symptoms of vertigo are due to dysfuncti on of the vesti bul ar system i n the i nner ear. Defi niti ve treatment of verti go depends on treati ng the underl yi ng cause.

Vertipress (Betahi sti ne hydrochl oride) is a drug i ndicated i n the treatment of Meni ere's di sease and more gener al l y of peri pheral verti go di sorders of di fferent ori gi ns. Addi tionally, betahi sti ne al so takes care of ti nni tus and deafness associ ated with Meni ere's di sease.

The mechani sm of acti on of betahi sti ne i s based on its i nteracti on with H H 3 receptors. Betahi sti ne has a w eak H antagoni sti c effect on H
3 1

and

receptor agoni st acti on and a potent

receptors.

Dosage and admi ni strati on: I ni tial oral treatment is 8 to 16 mg three ti mes daily, taken wi th food.

Mai ntenance doses are general l y i n the range of 24 mg to 48 mg dail y.

Vertipress i s not recommended for use i n i ndi vi dual s below 18 years of age.

Decemb er 2010

Top Febuci p The Sel ective, Non-purine XO inhi bitor

Gout i s a di sorder of puri ne metabol i sm and resul ts from urate crystal deposi tion i n and around the joi nts caused by l ongstandi ng hyperuri caemi a.

Febuxostat i s a xanthi ne oxi dase i nhi bitor and achieves i ts therapeuti c effect by decreasi ng serum uric aci d (sUA). It i s the first agent approved i n the Uni ted States for the treatment of gout si nce al lopuri nol was first marketed i n 1964. It is

y y y

Non-purine analogue - does not structurall y resembl e puri nes and pyri midi nes. Selective sel ectivel y i nhi bi ts xanthi ne oxidase and not the other addi tional enzymes of the puri ne and pyri mi dine pathw ay. Potent i nhi bits both the oxi dized and reduced forms of xanthi ne oxi dase.

Febuxostat i s i ndi cated for the chroni c management of hyperuri caemi a i n pati ents wi th gout.

For the treatment of hyperuri caemi a i n pati ents with gout, FEBUCIP is recommended at a dosage of 40 mg or 80 mg once dail y.

The recommended starti ng dose is 40 mg once dail y. For pati ents who do not achi eve a sUA < 6 mg/dL after 2 w eeks wi th 40 mg, FEBUCIP 80 mg i s recommended. FEBUCIPcan be taken wi thout regard to food or antaci d use.

Gout flares may occur after i niti ation of FEBUCIP due to changi ng sUA l evel s, resul ti ng i n mobilizati on of urate from ti ssue deposi ts. Fl are prophyl axis wi th an NSAID or col chi ci ne is recommended upon i ni ti ation of therapy wi th FEBUCIP . Prophyl acti c therapy may be benefi cial for up to 6 months. If a gout fl are occurs duri ng FEBUCIP treatment, they need not be di sconti nued. The gout fl are shoul d be managed concurrentl y, as appropri ate for the i ndi vi dual pati ent.

Febuxostat i s contrai ndi cated i n pati ents bei ng treated wi th azathi opri ne, mercaptopuri ne or theophylli ne.

No dose adj ustment i s necessary i n pati ents with mil d or moderate renal and hepati c impai rment . Cauti on shoul d be exerci sed i n severe renal and hepati c impai rment pati ents.

FEBUCIP i s avail abl e i n 2 strengths - 40 mg and 80 mg.

November 2010

Top SORNIP cream Answeri ng the Unanswered

Psori asi s is a lifelong disease that waxes and w anes over time. It affects 1 to 3% of the worl d' s popul ati on. Peopl e wi th psori asi s have to l ive wi th thi s chroni c di sease for whi ch there i s no known cure. Adequate treatment can, however, reli eve the symptoms and mai ntai n remi ssion. Duri ng their li fetime, pati ents will undergo a range of treatment options to achi eve the desi red goal s.

Vari eties of systemi c and topi cal agents are avail abl e for the treatment of psori asi s, but the l atter remai ns the mai nstay of treatment for most pati ents, especi al ly those with li mi ted di sease. But, many of these agents have certai n li mitati ons.

There i s a constant research for an opti mum therapeuti c opti on. An i nnovati ve formul ati on, SORNIP cream which contai ns the resi n extract of the Bosw elli a serrata tree i s introduced for the treatment of mil d to moderate psori asi s. The acti ve ingredi ent i nSORN IP cream i s the 3-0-acetyl keto beta boswellic aci d.

SORN IP cream has benefi ci al effects i n psori asi s because of its anti i nfl ammatory and i mmunomodul atory acti vi ty; thus, it sl ows down or normalizes the excessi ve kerati nocyte prol iferation and reduces the i nfl ammati on associated wi th psori asi s.

SORN IP cream can be used as a monotherapy to treat mil d and l ocali zed psori asi s. It may have a potenti al to be used as a combi nati on therapy for pati ents wi th moderate and severe di sease. It can al so be used duri ng the steroi d-free holi day periods and as a mai ntenance treatment opti on.

SORN IP cream is requi red to be appl i ed as a thi n l ayer on the psori ati c l esi ons three ti mes dail y (of which one appli cati on shoul d be before bedti me).

It i s avai labl e in a 30 gm l ami tube pack.

October 2010

Top Ci pla Launches PIRFENEX (Pirfenidone 200 mg) in India for Idiopathic Pulmonary Fibrosis

Idiopathi c pul monary fi brosi s (IPF) is an i nevi tabl y progressi ve form of l ung di sease, with a di smal prognosis for whi ch, until recentl y, there were no effecti ve and approved treatments.IPF has a medi an survival from di agnosi s of 2.8-4.2 years w hi ch is l ess than many cancers. In idiopathi c pul monary fi brosis, epi thelial i njury by an unknown i nci ti ng agent i n a susceptibl e host and abnormal wound heal i ng l eads to fibroproliferati ve and i nflammatory changes i n the l ungs. Eventuall y this leads to severe dyspnoea i n the pati ent wi th most pati ents dyi ng of respi ratory failure.

PIRFENEX (Pi rfeni done) i s the fi rst and onl y approved drug for the treatment of IPF. Pirfeni done exerts i ts effect by down regul ating the transcri ption of key profi broti c growth factors incl udi ng TGF- , reduci ng i nflammatory cytoki nes such as TNF- E and through reducti on in li pid peroxi dation and oxi dati ve stress. It i s a novel anti -fi broti c drug w hich through cli ni cal tri als has shown to slow dow n progression of thi s termi nal disease as measured by decli ne i n forced vi tal capaci ty over 36-72 weeks and stabili zes lung functi on. As per a recent Cochrane anal ysis, pi rfeni done i s the onl y drug which i mproves progressi on free survi val i n IPF pati ents by 30%. In general, in these cl ini cal tri als, pirfeni done was safe and well tol erated.

Hence i ntroduction of pi rfeni done offers hope and opens up a new path i n the treatment of IPF pati ents.

Click here for ful l prescribi ng informati on

Click here for product monograph

October 2010

Top PANSTAL: Ensures the Real Value of Food

Pancreati c Exocri ne insuffi ci ency (PEI) i s caused by a generalized reducti on i n pancreati c enzyme producti on and deli very, l eadi ng to severe i mpai rment i n fat absorpti on wi th steatorrhoea (greasy foul smel li ng stools).

PEI i s associ ated with condi ti ons like chroni c pancreati ti s, after pancreati c or major gastro i ntestinal surgery, obstruction of pancreati c or common bil e duct and cysti c fi brosis.

Symptoms and si gns other than steatorrhoea i ncl ude abdomi nal cramps after meal s, abdomi nal bloati ng, mal absorpti on, wei ght l oss and even chroni c mal nutri ti on if l eft untreated. About 80% of pati ents after pancreati c surgery and 50% of pati ents wi th chroni c pancreati ti s develop PEI associ ated mal digestion i n 10 to 12 years from the onset of the di sease. Hence recogni tion of thi s condi ti on and an appropri ate repl acement therapy is hi ghl y rel evant to avoi d mal nutri tion-rel ated morbidi ty and mortali ty.

The management of PEI i ncl udes correction of the underl ying cause or di sease, di etary supervi si on and oral admi nistrati on of pancreati c enzyme repl acement therapy (PERT).

PERT ai ms at provi ding pancreati c enzymes i n the duodenal l umen wi th suffici ent acti ve li pase at the ti me of gastri c emptyi ng of nutri ents. These pancreati c enzymes then hel p break down fats, protei ns and carbohydrates i n food, thereby acti ng as a repl acement for di gesti ve enzymes physiologicall y secreted by the pancreas.

Key highlights: PANSTAL CAPSULES

Have enteri c-coated granul es to avoi d aci d-medi ated i nactivati on of li pase and ensure gastri c emptyi ng of enzymes i n parall el with nutri ents.

Rel ease the acti ve pancreati c enzymes wi thi n the proxi mal i ntesti ne wi th a hi gh therapeuti c effi cacy.

Are wi dely accepted as the therapy of choi ce for mal digestion secondary to pancreati c exocrine i nsuffi ciency of any aeti ology.

Each capsul e contai ns: Pancreatin IP 150 mg equivalent to: Li pase .. 10,000 PhEur uni ts Amyl ase 8,000 PhEur uni ts Protease 600 PhEur uni ts (as enteri c coated granul es)

PANSTAL Capsules are i ndicated for pati ents wi th pancreati c exocri ne i nsuffi ci ency, which is often associ ated with the followi ng: chroni c pancreati tis , after pancreatectomy or gastroi ntesti nal bypass surgery, ductal obstructi on from a neopl asm (pancreas or common bil e duct) and cystic fi brosi s.

The dosage of PANSTAL Capsules shoul d be i ndivi duali zed based on cl i nical symptoms, the degree of steatorrhea present, and the fat content of the di et.

Generall y for chil dren (below 6 years of age) usual i niti al starti ng dosage i s up to onePANSTAL Capsule per meal or snack. For adul ts and chil dren (over 6 years of age) the usual i ni ti al starti ng dosage i s one to two PANSTAL Capsules per meal or snack.

PANSTAL Capsule shoul d be taken during meals or snacks , with suffici ent fl ui d. The capsul es can be swal lowed whol e, or for ease of admi ni strati on they may be opened and the granul es taken wi th flui d or soft food (appl e puree or mashed vegetabl es) but without chewi ng followed wi th a gl ass of w ater or jui ce to ensure compl ete i ngestion.

October 2010

Top Rosulip-F: A Class Apart Combination

Stati n therapy i s clearl y established as an effective treatment for low eri ng LDL-C l evels and i s the cornerstone of dysli pi demi a management. However, 60% of vascul ar complicati ons still occur despite stati n therapy. Hence, thi s means that a parti cul ar residual ri sk stil l persi sts w hi ch we must effecti vel y address to reduce the cli nical and economi c burden. Thi s resi dual risk can be effecti vel y tackl ed with a stati n-fi brate combi nation. Also, stati n and fenofi brate therapy

have been associ ated wi th reducti on in the risk of vari ous macrovascul ar and mi crovascul ar complicati ons of diabetes.

Rosuvastati n i s the most potent stati n with a safety profil e comparabl e to other stati ns, w hile fenofi brate i s effecti ve i n loweri ng TG and i ncreasi ng HDL-C. The combinati on ofrosuvastatin and fenofibrate therefore constitutes an optimal therapeuti c appro ach for providing optimal treatment of atherogeni c dyslipidemia and managing vascularcomplications.

RO SU LIP-F is avail abl e i n two strengths: RO SU LIP-F5 (5 mg rosuvastati n with 145 mg fenofi brate) and RO SU LIP-F10 (10 mg rosuvastati n with 145 mg fenofi brate).

INDICATIONS RO SU LIP-F is i ndi cated as an adjunct to di et for treatment of mixed dysli pidemi a, hyperchol esterol emi a and hypertri gl yceridemi a.

DO SAGE AN D ADMINISTRATION Pati ents shoul d be pl aced on an appropri ate l ipid-loweri ng di et before recei vi ngRO SU LIP-F , and shoul d conti nue thi s di et duri ng treatment. The recommended dosage i s one tabl et once dail y

RO SU LIP-F cannot be used to i niti ate dosing i n pati ents having mil d to moderate i mpai red renal functi on and shoul d be admini stered onl y after eval uati ng the effects of rosuvastati n and fenofi brate on renal functi on and li pi d l evels.

October 2010

Top Pararcip: Infusing Relief

Pai n is a major concern i nfl uenci ng every aspect of li fe. Pai n i s often cal l ed the fi fth vital si gn in conj uncti on wi th temperature, pul se, respi rati on and blood pressure. Though pai n serves the useful purpose of warni ng i t imposes several emoti onal , physi cal and economi cal stresses on the pati ent. Thereby, there is a need to ease the sufferi ng and i mprove the qual ity of life of those livi ng wi th pai n.

Introduci ng PARACIP sol ution for i nfusi on, contai ni ng 1g paracetamol for

i ntravenous i nfusion.

Paracetamol has been widel y used for over a century as an effecti ve anal gesic and as an anti pyreti c agent. Its efficacy and tol erability are wel l established and i n contrast to other anal gesi cs, it has a favourable safety profi le.

PARACIP can al so be used as an effecti ve component i n mul timodal anal gesi a i n combi nati on with opioids and NSAIDs.

PARACIP sol uti on for i nfusi on i s i ndicated for

y y

The short-term treatment of moderate pai n, especi ally followi ng surgery The short-term treatment of fever, w hen admi ni strati on by i ntravenous route i s cli nically justifi ed by an urgent need to treat pai n or hyperthermi a and/or when other routes of admi ni strati on are not possi bl e.

DO SAGE AN D ADMINISTRATION

PARACIP i s avail abl e as a 100ml soluti on for i nfusion contai ni ng 1g paracetamol.

PARACIP shoul d be admi nistered as a 15-mi nute i ntravenous infusion, and i s for si ngle use i n one pati ent onl y.

PARACIP sol uti on for i nfusi on shoul d not be mi xed with other medi ci nal products

Paracetamol 1 g per admi nistrati on, i.e. one 100 ml vi al, can be used up to four ti mes a day. The mi nimum i nterval betw een each admi ni stration must be 4 hours i n pati ents without hepati c impai rment. In pati ents with renal and/or hepati c impai rment the mi ni mum i nterval between doses must not be l ess than 6 hours.

The maxi mum dai l y dose from all sources of paracetamol must not exceed 4 g.

September 2010

Top FLOSOFT: Smart & Safe

Infl ammati on i s the body's protective response to a sti mul us i t recogni zes as offensi ve. Whil e i nflammati on i s protecti ve for the body as a whol e, the i nfl ammatory processes can cause scarri ng and damage to the surroundi ng heal thy ti ssue. Corticosteroi ds are used to preserve the normal structure of the ti ssues. They were devel oped i n the 1940s, and till date remai n the most potent agents for managi ng i nfl ammati on. Fl uorometholone is one such steroi d used for the management of i nfl ammatory and allergi c condi tions of the eye.

Earli er fl uorometholone w as avai l abl e as an al cohol deri vati ve but now even the acetate deri vati ve i s avai labl e. The deri vati ves of steroi d base (acetate, al cohol and phosphate) i nfl uence the bi oavail abi lity i.e. they determi ne the abi li ty of steroi d to penetrate the anteri or chamber. Acetate and Al cohol derivati ves are sol ubl e in hydrophobi c medi a whereas phosphate derivati ve i s sol ubl e i n hydrophili c medi a. In the normal eye, an acetate deri vati ve penetrates the best through the cornea, followed by al cohol s, and then phosphates.

The deri vati ves of steroi d base (acetate, alcohol and phosphate) al so infl uence the bioacti vity of that steroi d so accordingl y fl uorometholone acetate shows superi or anti i nfl ammatory acti vity in the cornea than fl uoromethol one al cohol.

FLO SOFT contai ns Fl uoromethol one acetate 0.1%. It is the Worl d's fi rst formul ati on with SOC (Stabi li zed Oxychlorocompl ex) as the preservati ve. SOC i s i ntroduced as an ophthal mi c preservati ve i n 1996. Once i t enters the eye, i t breaks i nto water and sal t i.e. sodi um and potassi um ions (NaCl ), these components are al ready found i n natural tears. Also i t has no effect on mammali an cell s. Hence i t is more comfortabl e than other preservati ves (Benzal koni um chlori de).

INDICATIONS FLO SOFT (fl uorometholone acetate ophthal mi c suspension) i s i ndi cated for use i n the treatment of steroi d responsi ve i nflammatory condi tions of the pal pebral and bul bar conjuncti va, cornea, and anteri or segment of the eye.

DO SAGE AN D ADMINISTRATION Shake Well Before U si ng. One to two drops i nstill ed i nto the conjuncti val sac(s) four times dail y. Duri ng the i ni ti al 24 to 48 hours the dosage may be safel y i ncreased to two drops every two hours. If no improvement after two weeks, consul t physi ci an. Care shoul d be taken not to disconti nue therap y prematurel y.

FLO SOFT: Highlights

1.

Worl d's first formul ation of Fluoromethol one acetate wi th SOC as a preservati ve

2.

Parti cl e Si ze between 1-3 : Uni form Parti cle di stri bution and No aggl omerati on

3.

As effecti ve as Predni sol one and Dexamethasone i n reducing corneal i nfl ammation

4.

Shows superi or anti i nfl ammatory effect i n the cornea as compared to Fl uorometholone al cohol

5.

Fl uorometholone acetate has l ow propensi ty to el evate IOP, therefore

o o o

Can be gi ven to old age pati ents sufferi ng from gl aucoma Can be gi ven to Steroi d responders Can al so be given i n chroni c therapy, requi ri ng l onger period of ti me

September 2010

Top IMUDROPS: TREA T BEYOND THE SURFA CE

Dry eye i s a mul tifactori al disease of the tears and ocul ar surface that resul ts i n symptoms of di scomfort, vi sual di sturbance and tear film instabi lity with potenti al damage to the ocul ar surface. It is accompani ed by i ncreased osmol arity of the tear film and i nfl ammation of the ocul ar surface.

A number of anti -infl ammatory agents have been evaluated for treatment of pati ents wi th dry eye, i ncl udi ng cyclospori ne-A, pimecrolimus, tacrolimus, and corti costeroi ds.

Cycl ospori ne may represent the fi rst product for dry eye that actuall y treats the cause and not the symptoms of dry eye.

To improve del ivery of cyclospori ne to ocul ar tissues, a microemul sion formul ati on i n castor oil i s devel oped that produces sustained cyclospori ne concentrati ons suffici ent for i mmunomodul ati on .

IMUD ROPS : Technology features

y y y

Uni que mi cro emul sion technol ogy provi des cyclospori ne parti cle si ze of l ess than 1 mi cron Better, faster absorpti on and penetrati on Negli gibl e local i rritation, burni ng and sti ngi ng reacti on

Topi cal cyclospori ne emul si on has al so been i nvesti gated for the treatment of other ocul ar surface di sorders that may have an i mmune based i nfl ammatory component. In these tri al s , cyclospori ne 0.05% ophthal mic emul sion has shown effi cacy for management of posteri or bl ephari ti s , ocul ar rosacea , post-L ASIK dry eye , contact l ens intolerance , atopi c keratoconjuncti vi ti s, graft versus host di sease and herpeti c stromal keratiti s . As these di sorders are often refractory

to another avail abl e treatments , ophthal mi c cyclospori ne is a w el come non toxic adjunct or repl acement to potenti ally toxi c topi cal or systemi c immunosuppressi ve therapi es.

Cyclosporine ( IMUDROPS) Key HIGHLIGHTS

y y y y y y y

Potent i mmunomodul ator that acts sel ecti vel y and l ocally US FDA approved treatment for KCS Si gni ficant breakthrough i n the manag ement of dry eyes Immunomodul atory, lacri mogeni c and muci n enhanci ng property Restores the body' s abi lity to produce natural healthy tears Stops the progressi on of dry eye disease Si gni ficant decrease i n the artifi cial tears use

IMUD ROPS : Indications and Usage To i ncrease tear producti on i n pati ents whose tear production is presumed to be suppressed due to ocul ar i nfl ammation associ ated with keratoconjuncti viti s si cca.

IMUD ROPS : Dosage and Administration

y y y y

Invert the uni t dose vi al a few times to obtai n a uniform, mi croemul sion before usi ng. Instill one drop of Imudrop ophthal mi c microemul sion twice a day i n each eye approxi matel y 12 hrs apart. Imudrops can be used concomi tantl y wi th artifi cial tears, allowing a 15 mi nute i nterval between products. Di scard vi al immedi atel y after use.

September 2010

Top AZIPRODelivers the Difference

Communi ty-acqui red respiratory tract i nfections cause consi derabl e morbi dity and mortal ity. Most of these are upper respi ratory tract i nfecti ons with approxi matel y one thi rd of RTI's invol vi ng the l ower respi ratory tract. The use of short-course anti microbi al therapy has potenti al economi c benefi ts, i ncl uding reduced acqui si tion cost, i mproved adherence (compli ance), reduced adverse events, reduced offi ce visi ts and i ncreased pati ent satisfacti on.

Azithromycin is the sole member of the macroli de sub-classthe azal ides. Due to i ts al tered chemi cal structure, azi thromyci n is characterized by a broader spectrum of acti vity (coveri ng gram posi tive, gram negati ve, anaerobes, atypi cals and many others), low er i ncidence of adverse events and drug i nteractions and an excell ent pharmacoki neti c profile. The pati ents are al so abl e to compl ete a course of azi thromyci n withi n a shorter timeframe as compared to other anti biotics.

Azi thromyci n is approved for use i n the treatment of acute exacerbati ons of chroni c bronchi ti s (AECB), mil d-to-moderate communi ty acqui red pneumoni a (CAP), acute bacteri al si nusi tis, pharyngiti s/tonsi lliti s, uncompli cated ski n and ski n structure i nfections and pel vi c infl ammatory disease (PID).

Azi thromyci n is avail able as 250 mg, 500 mg oral tabl ets, 500 mg IV i nj ection and 2 gms sustai ned rel ease wi th microsphere technol ogy.

Mi crosphere technol ogy is an advanced drug delivery system that uses mi crospheri cal shaped parti cl es to rel ease the drug sl owl y i n the l ower GI tract. Azi thromyci n is embedded i n the mi crospheres, whi ch enabl e the deli very of

azi thromyci n as a compl ete course of therapy i n a si ngle dose. The mi crospheres mi ni mize the rel ease of azithromyci n i n the stomach, thereby mi ni mi zing GI si de effects; i nstead, they pass through the stomach i mmedi atel y and i nto the small i ntesti ne w here the acti ve i ngredi ent is sl owly rel eased.

Azi thromyci n demonstrated good cli ni cal and bacteri ological efficacy i n AECB, CAP, acute bacteri al si nusi ti s, pharyngi ti s / tonsilliti s, uncompl icated ski n and ski n structure i nfections and PID and was generall y well tol erated. Thus, Azi thromyci n is a good opti on for the treatment of adul t and adol escent pati ents.

Dosage and Administrati on:

Oral tabl ets i n Adul ts

CAP (mi ld severi ty) Pharyngi ti s/tonsilli tis (second li ne therapy) Ski n/ski n structure (uncompli cated)

500 mg as a si ngl e dose on Day 1, fol lowed by 250 mg once dail y on Days 2 through 5. 500 mg OD x 3 days OR

AECB (mil d to moderate)

500 mg as a si ngl e dose on Day 1, fol lowed by 250 mg once dail y on Days 2 through 5.

Acute bacteri al sinusi tis

500 mg OD x 3 days

Injection i n Adul ts

CAP

500 mg as a si ngl e dail y dose by the IV route for at l east two days.

IV therapy shoul d be followed by azi thromyci n by the oral route at a si ngl e, dail y dose of 500 mg, admi nistered as two 250-mg tabl ets to compl ete a 7- to 10-day course of therapy. 500 mg as a si ngl e dail y dose by the IV route for one or two days. IV therapy Pel vic i nfl ammatory di sease shoul d be followed by azi thromyci n by the oral route at a si ngl e, dail y dose of 250 mg to compl ete a 7-day course of therapy.

The i nfusate concentrati on and rate of i nfusi on for AZIPRO (azi thromyci n for i njecti on) shoul d be ei ther 1 mg/mL over 3 hours or 2 mg/mL over 1 hour.

AZIPRO (azi thromyci n for i nj ection) shoul d not be given as a bol us or as an

i ntramuscul ar i njecti on.

Azi thromyci n sustai ned rel ease AZIPRO shoul d be taken as a si ngl e 2 g dose.

AZIPRO (azi thromyci n SR) shoul d be used wi thi n 12 hours of mixi ng (do not refri gerate) and be taken on an empty stomach (at least 1 hour before or 2 hours fol lowi ng a meal )

August 2010

Top LEVOLIN AUTOHALER

Experience relief with never before ease

Levolin (levosal butamol ) Autohaler is the w orld's first - easy to use, breath actuated i nhal er (BAI).

Levosal butamol or (R)-sal butamol is the pure, therapeuti cal ly active i somer of sal butamol . It is a potent bronchodi l ator, effecti ve at hal f the dose of sal butamol wi th a qui ck onset of acti on. The enti re bronchodilatory acti vi ty of racemi c sal butamol is attri butabl e to (R)sal butamol . (S) sal butamol has been show n to have no bronchodil atory or bronchoprotecti ve acti vity. In fact studi es have show n that (S) sal butamol mi ght have pro-i nfl ammatory properti es.

Levosal butamol is avail abl e as Levoli n rotacaps to be used with Rotahal er/Revoli zer, pressuri zed metered dose i nhal er (pMDI), respul es to be used wi th nebul izer. Now l evosalbutamol is also availabl e as Levolin Autohaler. It i s i ndicated for the treatment or preventi on of bronchospasm i n

adul ts, adol escents and chil dren with reversi bl e obstructi ve ai rw ay di sease.

Levolin Autohaler overcomes the key probl em of the pMDI vi z. coordi nati on of actuati on wi th i nhal ati on and does not rel y on the pati ent`s i nspi ratory effort to aerosoli ze the dose of medi cati on unli ke dry pow der inhal ers. Levolin Autohaler i s acti vated at l ow fl ow rates of 22-30 l /sec. Studi es have show n that the Autohal er TM i s easi er to use and to teach as compared to pMDIs and some of the DPIs. It can also be used by children who are wheezi ng, ol der pati ents wi th severe ai rflow obstruction and those with arthri ti s. AutohalerTM contai ns 300 doses, whi ch ensures l ong term preventi ve i nhalation for the pati ent, thus offers better adherence and compliance.

Now, Autohaler TM i s avai l abl e as a compl ete therapy for pati ents, viz. control ler and reli ever as Seroflo Autohaler and Levolin Autohaler respecti vel y.

For more informati on on autohal er devi ce, l og onto: www.ci pl aautohal er.com

July 2010

Top ZOLMIST: Head to Relief in Minutes

Mi grai ne i s a common, frequentl y i ncapaci tati ng, headache di sorder characteri zed by epi sodi c attacks of moderate-to-severe headaches, and vari ous combi nati ons of neurologi cal, gastroi ntesti nal and/or autonomi c nervous system dysfuncti on. It is esti mated that mi grai ne affects 12% of the general popul ation. It i s 3-ti me more common i n femal es as compared to mal es; with preval ence of

18% i n women and 6% i n men. It is a di sabli ng conditi on and i ncurs a heavy toll i n terms of treatment costs, pati ent di sabi li ty, and pati ent quality of li fe. In fact, Worl d Heal th Organi zation has l abel ed severe mi graine, along with quadri plegi a, psychosi s and dementi a, as the most di sabl i ng chroni c condi tion.

Mi grai ne management has two w ay approach: a) prophyl acti c therapy when the pati ent has frequent mi grai ne attacks ( > 2 attacks i n a month) medi cati on is used to prevent the future mi grai ne attack; b) abortive therapy when the pati ent has rare mi grai ne attacks, drugs are used onl y after the attack to reduce pai n, associ ated symptoms & i mprove quali ty of life.

Tri ptans are used for aborti ve treatment of mi grai ne & i s a drug w hi ch shoul d be used onl y w hen the di agnosi s of migrai ne is confi rmed as it i s a drug speci fi c for mi grai ne treatment. From the cl ass of triptans; sumatri ptan, rizatri ptan & naratri ptan were avai l abl e i n Indi a . Ci pl a took an i ni ti ati ve not onl y to i ntroduce a new tri ptan i e. zol mitriptan i n Indi a but it has l aunched zol mitri ptan i n nasal form, with brand nameZOLMIST. Thi s revol utionary drug-devi ce combi nation offers several advantages over oral and parenteral formul ations i n migrai ne pati ents.

The key benefi t of usi ng zolmi tri ptan i n nasal formul ati on is the rapi d onset-ofaction.Rel ief from mi grai ne is obtai ned as earl y as 10 mi nutes post-dose of i ntranasal zol mitri ptan. Studi es have shown that zomi tri ptan nasal spray yi elds consi stent and si gni ficantl y hi gher headache response rates, reli ef from migrai ne symptoms and pai n-free rates as compared to pl acebo and oral zol mitri ptan. Besi des, hi gher number of pati ents w ere abl e to return back to thei r normal routi ne i n just 2 hrs post zolmi tri ptan use. Apart from the effi cacy, pati ent sati sfacti on i s an i mportant parameter i n migrai ne therapy. Pati ent sati sfacti on studi es wi th zol mitri ptan nasal spray show that around 70-80% of pati ents are sati sfi ed with i ntranasal zolmitri ptan. Speed of onset and effi cacy were the 2 key factors cited by many pati ents preferri ng zolmitri ptan nasal spray over thei r previ ous therapy. Zol mitri ptan has a good tol erability profil e wi th no major adverse event. Both safety & effi cacy for i ntranasal zol mitri ptan has been eval uated & establ ished for a peri od of one year.

In fact, ZOLMIST has been studi ed i n Indi an pati ents & i t was found to be effecti ve & safe for mi grai ne treatment. Overall 74% of pati ents i n the study were sati sfied wi th ZOLMIST& 84% w ere willing to use it in future.

One vi al of ZOLMIST contai ns seven metered doses of zolmi tri ptan. The recommended dose of ZOLMIST is one spray (i.e. 5 mg). If headache returns, the dose may be repeated onl y after 2 hours. The maxi mum dosage of ZOLMIST shoul d not exceed more than tw o sprays (i. e. 10 mg) i n 24 hours.

Thus, ZOLMIST , w hich i s a new addi ti on to the l ist of India 's first brands by Cipla , targets to offer qui ck & consistent benefi ts i n mi grai ne pati ents & hel p mi grai ne pati ents to head towards rel ief in minutes .

July 2010

Global Pres ence

Exports for the fi nanci al year ended March 31, 2010 amounted to more than Rs. 29, 000 milli on. Ci pl a exports raw materi al s, intermediates, prescri ption drugs, OTC products and veteri nary products. Cipl a al so offers technol ogy for products and processes. Technical know -how/fees recei ved duri ng the year 2009-10 amounted to about Rs. 1500 mi lli on. Ci pl a's manufacturi ng faciliti es have been approved by vari ous internati onal regul atory authori ti es i ncl udi ng: Food and Drug Admi nistrati on (FDA), USA Medi cines and Heal thcare products Regul atory Agency (MHRA), UK Therapeuti c Goods Admi ni stration (TGA), Australi a Medi cines Control Counci l (MCC), South Afri ca Nati onal Institute of Pharmacy (NIP), Hungary Pharamaceuti cal Inspecti on Conventi on (PIC), Germany Worl d Heal th Organi sation (WHO) Department of Heal th, Canad a State Insti tute for the Control of Drugs, Sl ovak Republic ANVISA, Brazil

Ci pl a products are bought by over 180 countri es located i n the foll owing regions:

Cipla In The New s

Archives

02 March 2011 Cipla introduces new pain free screening technology for early detection of breast

cancer in India - No Touch Breast Scan transmission of HIV/AIDS

30 November 2010 Cipla extends an innovative Mother-Baby Pack for preventing mother-to-child 20 October 2010 Cipla launches the worlds first generic Pirfenidone in India, giving hope to sufferers

of IPF (Idiopathic Pulmonary Fibrosis)

06 July 2010 Life sciences industry in Asia grew 3.4% in 2009: survey 10 April 2010 Public Notice 23 March 2010 Piramal Healthcare Acquires "i-pill", a Leading Emergency Contraceptive Brand from

Cipla

12 November, 2009 Cipla launches generic drug to treat H1N1 25 September, 2009 Pharmaceuticals Export Promotion Council Awards 15 July, 2009 Cipla FY09 net up 10% at Rs 771 cr

read m

23 June, 2009 Pharma market grows 10% in May 12 June, 2009 Swine flu declared a 'pandemic', first in 41 years 07 May, 2009 Cipla Pharmaceuticals' Yusuf Hamied: 'I Am Not Against Patents ... I Am Against

Monopolies'
06 May, 2009 Cipla Gets Tentative USFDA Approval 02 May, 2009 St gives thumbs down to cos with foreign ops 01 May, 2009 New Delhi rejects American firm's plea to patent Hepatitis B drug 27 April, 2009 Cipla wins Erlotinib case against Roche 25 April, 2009 Cipla Q4 net profit up on better product-mix 02 March, 2009 Pharma retail market grows 15% 25 February, 2009 Patents yes, but monopoly no 03 December, 2008 Cipla gets USFDA nod for Pamidronate disodium injection 27 October, 2008 Pharma holds steady, Cipla pips Ranbaxy 23 July, 2008 Cipla: Active in overseas markets 07 July, 2008 Cipla Gets Thumbs Up for Generic HIV Drug 01 July, 2008 Cipla gets patent for Nexium, Fosamax modified versions 23 June, 2008 Cipla gets tentative approval from USFDA 05 May, 2008 Cipla offers free know-how of essential drugs to PSUs 30 April, 2008 Cipla: Overseas sales a booster 20 March, 2008 Cipla scores a generic win over Roche 01 January, 2008 Cipla maintains No.1 position in Indian mkt

Wednesday, 02 March 2011

Ci pla introduces new pain free screening technology for early detection of breast cancer in India - No Touch Breast Scan

Ci pl a, one of the l eadi ng pharmaceuti cal compani es from Indi a, today announces the l aunch of a breakthroug h screeni ng technol ogy i n Indi a today call ed the N o Touch Breast Scan (N TBS); ' the first-ever painl ess, non-invasive and radiation-free breast scanning techni que for detecti ng breast cancer at an earl y stage.

As of today, 1 in every 22 women i n Indi a i s expected to be di agnosed wi th breast cancer i n thei r lifetime.

Dr. Shekhar Kulkarni, Consultant Breast Canc er Surgeon, Magnoli a Breast Surgery Cli ni c, Pune sai d, Breast cancer i s risi ng rapidl y among urban women and i s now the most common cancer i n ci ties such as Mumbai and Del hi . Unfortunatel y most cancers are diagnosed when the di sease is advanced l eadi ng to low chances of cure. Al though Mammography has been avail abl e for years i t i s not used that wi del y. There are many reasons for i t such as l ack of awareness, pai n and di scomfort duri ng the procedure and a concern about repeated exposure to radi ation. Wel coming the introduction of N TBS in India , D r. Rakesh Sinha, Consultant Gynaecologist Surgeon, BEAMS Hospital , Mumbai said, The No-Touch Breast scan i s a pai nl ess option for women who wi sh to get themsel ves regul arl y screened. I t is of parti cul ar use i n younger women who have dense breasts and mammography i s i nconcl usi ve. If a woman shows changes on the NTBS then she i s sent for further i nvesti gation which i ncl udes mammography, sonography etc. At BEAMS Mumbai, of the 41 pati ents w ho have undergone the NTBS test, onl y 1 had to be referred for mammography.

Thermal imagi ng has been approved by the FDA several years ago for earl y di agnosis of breast cancer. With improvements i n di gital camera technol ogy duri ng the l ast few years, thermal imagi ng i s fast gai ni ng acceptance. Devel oped by UE Li fe Sci ences Inc, the No Touch Breast Scan' i s the Worl d' s fi rst full y computeri zed thermal imagi ng technol ogy' with dual IR cameras whi ch can fi nd thermal changes at l ess than 0.08 deg. C. The NTBS usi ng i nfrared i magi ng creates a sophi sticated heat-map of the breast wi thout usi ng any radi ati on. Breast cancer i s associated with i ncreased formati on of new bl ood vessel s and these show up as 'hot spots' w hi ch could i ndicate a cancerous growth.

At Dr Kul karni' s Magnol ia Beauty and Cli nic i n Pune, the NTBS test was taken by about 165 women and onl y 12 of them needed further i nvesti gation. Mrs. Ambi ke, an asymptomatic woman who has untaken the NTBS test said, I had taken a mammography test earl i er but i t was qui te traumati c. Wi th this totall y touchfree and qui ck NTBS test, I woul d not defer my annual check-up anymore.

The No-Touch Breast Scan' w oul d be excl usi vely marketed by Ci pl a across di agnostic centres and hospi tals i n Indi a . It has al ready been i nstal led at BEAMS Hospital , Mumbai and Indore and Magnol i a Beauty and Cl ini c, Pune and woul d be extended by Ci pl a on a requi rement-basi s to over 20 more di agnostic centres or hospital s across Indi a .Addressing the press, D r. Jaideep Gogtay, Medi cal Director Cipla said , Ci pl a has been worki ng i n the area of cancer by manufacturi ng drugs for the l ast 20 years but thi s i s for the fi rst ti me we have taken a step towards focusi ng on earl y diagnosi s of breast cancer.

There are 3 NTBS machi nes availabl e i n the US , UK , Turkey and Kazakhstan , but women i n Indi a woul d have greater access to thi s l andmark technology and have more control over thei r breast heal th.

The cost of per NTBS test woul d range between Rs 800 1000, dependi ng on the pri ci ng determi ned i ndivi dually by the hospi tal s and centres.

Quick Facts on Breast cancer in India

y y

Breast Cancer has practi call y repl aced cervi cal cancer as the l eadi ng site of cancer among w omen i n all urban cancer regi stri es As of today, 1 in every 22 women i n Indi a i n thei r li fetime i s expected to be di agnosed with breast cancer

y y y y y

More than 92% of breast cancers are di agnosed at stage II or later 1 out of every 2 women di agnosed with breast cancer does not survi ve the di sease; mostly due to l ate stage di agnosis. Counter to common thi nki ng, breast cancer i s i n fact a younger woman's di sease, i t is more preval ent i n urban than rural parts and the rates are dramati cal ly ri si ng, faster than any other femal e cancer. Accordi ng to a study by Internati onal Agency for Research on Cancer (IARC) a branch of WHO, there wi ll be approxi matel y 250,000 new cases of breast cancer i n Indi a by 2015. Accordi ng to Nati onal Insti tutes of Heal th, nearl y 90% di agnosed will survi ve at least 5 years

About Cipla:

Ci pl a l ai d foundations for the Indi an pharmaceuti cal industry back i n 1935 wi th the vi sion to make Indi a sel freli ant i n heal thcare. Over the years Ci pla has emerged as one of the most respected names not just i n Indi a but worldwide. Its state of the art R&D centre has gi ven the country and the worl d many fi rsts. This i ncl udes the revol utionary AIDS cocktail for l ess than a doll ar a day. Wi th over 40 manufacturi ng uni ts across the country, Ci pl a manufactures over 1200 products i n 80 therapi es.

Wi th a turnover of over US $ 1 bil lion, Cipl a serves doctors and pati ents i n over 183 countri es. It has earned a name for mai ntai ni ng one gl obal standard across all i ts products and servi ces. Ci pl a conti nues to support, improve and save millions of li ves wi th its hi gh-qual ity drugs and i nnovati ve devi ces. ( www.ci pl a. com )

Medi a Contact:-

Antara Mukherjee Corporate Communi cati ons Ci pl a Mob: (+91) 9967516441 E Mail : antara. mukherjee@ci pla.com

Jaisi ngh Bal akri shnan Corporate Communi cati ons Ci pl a Mob: (+91) - 9833836185 E Mail : jai si ngh.krishnan@ci pl a. com

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Tuesday, 30 November 2010

Ci pla extends an innovative Mother-Baby Pack' for preventing mother-to-child transmissi on of HIV/AIDS

India, 30 th November 2010: In keepi ng with i ts commitment to reduce mother-to-child transmi ssi on of HI V/AIDS, Ci pl a, one of the worl d's l eadi ng generi c pharmaceuti cal compani es has devel oped the first-of-its ki nd Mother-Baby Pack' i n coll aboration with UNICEF and other partners . The Mother-Baby Pack contai ns the enti re range of anti -retroviral drugs and anti bi otics requi red by an HIV i nfected mother starti ng from the 14 th week of pregnancy un til the 6th w eek after del ivery . Devel oped i n li ne with the l atest Worl d Health Organi zati on (WHO) gui deli nes on Preventi on of Mother-to-Chi ld Transmi ssion (PMTCT) Option A , the MotherBaby Pack i s a color-coded take-home ki t with si mple graphi cs to hel p mothers i dentify the different sets of drugs each to be taken duri ng pregnancy, duri ng l abour and breastfeedi ng, coveri ng the enti re peri od w hen the transmi ssion can occur. Al so, the pack contai ns drugs for the new born baby. Launched i n Kenya , Cameroon , Zambi a and Lesotho , the Mother-Baby Pack thereby addresses the l ogistical chal lenge of access to essenti al HIV drugs duri ng the enti re term of pregnancy and the suscepti bl e period thereafter.

Over 1,000 i nfants contract HIV everyday from thei r mothers at the ti me of bi rth with the hi ghest rate reported i n sub -Saharan Africa . The ri sk of transmission from an i nfected mother to her i nfant ranges from about 15% to 45%, wi th 25 to 35% transmi ssion occurri ng antenatall y, 70-75% of transmi ssion occuri ng

duri ng l abor and deli very and about 14% i s attri butabl e to breastfeedi ng. The i ntrapartum peri od provides a cruci al wi ndow of opportuni ty for preventi on. Wi th the l aunch of the Mother-Baby Pack, n ow an HIV positi ve mother-to-be even i n the remotest corner of the l east devel oped nati ons woul d have dail y access to essenti al PMTCT drugs duri ng her enti re term of pregnancy at the conveni ence of her own home. On maki ng another l andmark contri buti on i n the fight agai nst HIV/AIDS, Dr. Y. K. Hamied, Chai rman and Managing D irector, Cipl a sai d, We w ere approached by UNICEF to produce thi s pack for the PMTCT program. Ci pl a is proud to extend i ts world -class anti retroviral s to the i nfected expectant mothers and the speci ally designed MotherBaby Pack will i ncrease adherence and pl ay a pi votal rol e in the total preventi on of mother-to-child transmi ssion of HIV/AIDS.

The drugs for the Mother-Baby Pack are bei ng manufactured and packaged i n Ci pl a' s worl d cl ass manufacturi ng uni ts i n Goa and Patal ganga w hi ch are approved by WHO-Geneva, USFDA, MHRA-UK and various other regul atory bodi es.

Ci pl a's contri bution to PMT CT dates w ay back to the Nevi rapi ne donati on program' ai med at reduci ng the rate of mother-to-chil d transmi ssi on by 50% i n the developing countri es. Through thi s program, Cipl a offered the the anti -HIV drug Nevi mune' free of cost to any agency or Mi ni stry of Heal th that approached Ci pl a wi th its HI V/AIDS treatment programmes. Dr. Y. K. Hamied further added, Ci pl a w oul d make the Mother-Baby Pack avai l abl e to vari ous Mi ni stries of Heal th i n sub-Saharan Afri ca , vari ous NGO's and donor agenci es for thei r treatment programmes. Thi s rei nforces Ci pla's commi tment to make affordabl e medici nes accessi ble to all and its promi se that None shall be deni ed.

About Cipla's fight against HIV/AID S: At a ti me when the w orl d had al ready lost 20million peopl e to HIV/AIDS, the cost of HIV/AIDS treatment of at l east $12, 000 per pati ent per year had made the scienti fi c achi evements i n drug i nnovati on inaccessi bl e to the ordi nary peopl e of the devel opi ng nations who were w orst hi t with the di sease. Ci pl a then revol uti onized the treatment of HIV/AIDS i n 2001 by bri ngi ng down the cost of HIV treatment and maki ng the ARVs avai l abl e at below Doll ar a Day.' With the reduced cost of $300 per pati ent per year, HIV/AIDS treatment became a reality and the survi val rates went up dramati call y.

Further, Ci pl a's i nnovati on of a Fixed Dose Combi nation (FDC) i n 2001 of the tri ple cocktai l drug' call ed Tri omune w as a signi fi cant step w hi ch si mplified treatment and fostered adherence. Ci pl a was al so the fi rst to prepare a chil d-fri endl y three-i n-one paedi atri c formul ation (Tri omune Baby and Juni or) for the young popul ati on i nfected with HIV/AIDS. Ci pl a thereafter i niti ated a pati ent educati on campai gn Livi ng with Hope' i n 2004 and has been cond ucti ng several ongoing trai ni ng programs and CMEs i n Indi a and i nternational ly to cover vari ous aspects of HIV/AIDS treatment i ncl uding adul t, paedi atric, MTCT, PEP etc.

Currentl y, with more than 45 ARV formul ati ons i n its portfoli o, Ci pl a suppl ies these to over 120 countri es i ncludi ng various Mi nistri es of Heal th, Government of India and to several i nternati onal AIDS agenci es li ke UNICEF, MSF, SCMS/PEPFAR, Cli nton Foundati on, IDA, PAHO among others. Today, al most 1 out of 3 HIVi nfected pati ents i n the thi rd w orld is on Ci pl a drugs and Cipl a conti nues to work towards i ts commitment that

None shall be deni ed.'

About Cipla: Ci pl a l ai d foundations for the Indi an pharmaceuti cal industry back i n 1935 wi th the vi sion to make Indi a sel freli ant and sel f-suffici ent i n heal thcare. Over the years Cipl a has emerged as one of the most respected pharma names not just i n Indi a but worl dwide. Its R&D centre has gi ven the country and the w orl d many fi rsts. Thi s i ncl udes the revol utionary HIV/AIDS cocktail for l ess than a dollar a day. Wi th over 40 state of the art manufacturi ng uni ts across the country, Ci pl a manufactures over 1200 products i n 80 therapeuti c areas.

Wi th a turnover of over US $ 1.2 billion, Ci pl a serves doctors and pati ents i n over 180 countri es. It has

earned a name for mai ntai ni ng one gl obal standard across all its products and servi ces. Ci pl a conti nues to support, improve and save millions of li ves with i ts high-qual ity drugs and i nnovati ve devi ces. (www.cipla.com) Med ia Con tact :

Antara Mukherjee Head Corporate Communi cati ons Mob: (+91) 9967516441 E Mail : antara. mukherjee@ci pla.com

Jaisi ngh Bal akri shnan Corporate Communi cati ons Mob: (+91) 9773372487 E Mail : jai si ngh.krishnan@ci pl a. com

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Wednesday, 20 October 2010

Ci pla launches the world's first generic Pirfenidone in India, giving hope to sufferers of IPF (Idiopathic Pulmonary Fibrosis)

Ci pl a, among the world's l eadi ng generi c pharmaceuti cal compani es has i ntroduced Pi rfeni done i n Indi a; under the brand name Pi rfenex, for the treatment of IPF. A chroni c progressi ve form of lung di sease, IPF has averag e survi val rates as low as 3-5 years whi ch is l ess than many cancers. Ti ll now there i s no approved treatment for IPF. Pi rfeni done is a novel anti -fi broti c drug w hi ch through cli ni cal tri al s has shown to sl ow dow n progression of thi s termi nal disease and stabilize l ung functi on.

Ci pl a's techni cal prowess along wi th leadershi p i n terms of range of drugs and therapeuti c categori es in the respi ratory segment, i s l eadi ng the fight to provi de worl d cl ass affordabl e treatment for pati ents with orphan di seases. Commenti ng on the l aunch, Dr. Jai deep G ogtay, Medical Director, Cipla said, The l aunch of Pi rfenex i s a si gni ficant step forward. Wi th i ncreased availability and affordabil ity, Pi rfenex coul d now offer hope to those affl icted wi th thi s condi tion.

Pi rfenex wi ll be manufactured at Ci pl a's state-of-the-art manufacturi ng facili ty at Himachal Pradesh, Indi a whi ch i s approved by WHO, MCC South Afri ca and TGA Austral i a.

In addi tion to the l aunch, Ci pl a wi ll host and di ssemi nate a seri es of l ectures on IPF to physi ci ans i n Indi a and across the world. Addressi ng the del egates Prof Luca Richeldi, Director, Center for Rare Lung D iseases, Universi ty of Modena and Reggi o Emili a, Ital ysai d "Pati ents affected by IPF have a di sti ncti vel y poor prognosi s, and until now no drugs have been approved to treat IPF. Pi rfeni done represents the fi rst concrete chance of sl owi ng dow n di sease progressi on. The effect on i ncreasi ng progression free survi val, as showed i n three combi ned studi es, coupl ed wi th an acceptabl e safety profil e, opens up a new path for better manag ement of IPF."

Last year Cipla launched the world's first generic Bosentan, for the treatment of Pulmonary Arterial Hypertension. With the launch of Pirfenex, Cipla reaffirms its leadership in the respiratory arena with products and services in 8 therapeutic areas viz. asthma, COPD, allergic rhinitis, respiratory infections, pulmonary and critical care, pulmonary arterial hypertension, lung cancer and IPF.
About Cipla: Ci pl a l ai d foundations for the Indi an pharmaceuti cal industry back i n 1935 wi th the vision to make Indi a sel freli ant i n heal thcare. Over the years Ci pla has emerged as one of the most respected names not just i n Indi a but worldwide. Its state of the art R&D centre has gi ven the country and the w orl d many fi rsts. This incl udes the revol utionary AIDS cocktail for l ess than a doll ar a day. Wi th over 40 manufacturi ng uni ts across the

country, Ci pl a manufactures over 1200 products i n 80 therapi es.

Wi th a turnover of over US $ 1 bil lion, Cipl a serves doctors and pati ents i n over 180 countri es. It has earned a name for mai ntai ni ng one gl obal standard across all i ts products and servi ces. Ci pl a conti nues to support, improve and save millions of li ves wi th its hi gh-qual ity drugs and i nnovati ve devi ces. (www.ci pl a.com)

Medi a Contact : Jaisi ngh Bal akri shnan Corporate Communications M: (+91) 9773372487 Email: jai si ngh.kri shnan@ci pl a. com

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Busi ness Standard / Tuesday, 06 Jul y 2010

Life sciences industry in Asia grew 3.4% in 2009: survey BS Reporter

The Li fe Sci ences i ndustry i n Asi a cl ocked a grow th of 3.4 per cent to record revenues of $110.89 billi on i n cal endar year 2009, accordi ng to a survey by BioSpectrum Asi a, a journal for life sci ences i ndustry i n the Asi a Paci fic regi on. Li sted compani es contributed nearl y hal f the revenues at $54.24 billion as they grew at 24.03 per cent.

Bi oSpectrum Asi a estimates the growth of Li fe Sciences, coveri ng pharma, bi otech and medtech segments, i n 2010 to surpass that of 2009, even thoug h the range i s l ikel y remai n the same: 3 to 5 per cent, as the economi c climate begi ns to change for the better.

The combi ned revenues of Indi an life sci ences compani es was $21 billion taki ng Indi a to the number two spot behi nd Chi na. Indi a accounted for 19 per cent of the total revenues i n Asia Paci fi c. South Korea, Australi a and Si ngapore foll ow ed I ndi a i n terms of revenue.

Wi th revenues of $22 bill ion Chi nese publ icl y l isted compani es grew the fastest at 51.82 per cent, foll owed by Taiwan. Wi th revenues of $2 bi lli on, Tai wan posted a robust 46. 29 per cent growth. Indi an publi cl y l isted wi th revenues of $14.59 bil lion grew the slow est, at 1.42 per cent.

Seven Indi an compani es were i n the Asi a's Top 20 Publi cly Li sted Life Sci ence Compani es, w hi ch accounted for 82% of the overall revenues of publi cl y li sted compani es. These i ncl ude Ci pla, Ranbaxy Laboratori es, Dr Reddy's Laboratori es, Cadil a Heal thcare, Lupi n, Aurobi ndo Pharma and Sun Pharma.

Cipl a became India's N o. 1 company, clocking revenues of $1.17 billion. It also became the one of the two Indi an compani es i n the billi on-dol lar cl ub. Last year, Ranbaxy hel d Indi a's Top slot. The Indi a Top 20 Li fe Sci ences li st compri ses pharma compani es with the l one excepti on of a biopharmaBi ocon, at Rank 1 Bottom of Form

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Saturday, 10 Apri l 2010

Public Notice

Public Notice

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Public Notice - Envi ronmental Cl earance Letter

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Tuesday, 23 March 2010

Pi ramal Healthcare Acquires "i -pill", a Leading Emergency Contraceptive Brand from Ci pla
Mumbai, March 23, 2010: Pi ramal Heal thcare Li mi ted [NSE: PIRHEALTH, BSE: 500302] (Pi ramal ) and Ci pl a Li mi ted [NSE: CIPLA, BSE: 500087] (Ci pl a) today announced the si gni ng of a defi niti ve agreement for purchase of all intell ectual property rights i n Indi a rel ated to "i-pill" for an aggregate consi derati on of Rs 95 crore.

"i -pill" features i n the top-300 pharmaceuti cal products and recorded sal es of Rs. 31 crore for the previ ous 12 months as per data from ORG IMS. The acqui sition of "i-pill" strengthens Pi ramal' s over the counter (OTC) portfolio whi ch has strong consumer brands such as Lacto Cal ami ne ski n care range, Supracti v Compl ete, Sari don and Pol ycrol antaci d.

Commenti ng on the transacti on, Dr. (Mrs.) Sw ati A. Piramal, Executi ve Di rector - Strategi c Alli ances & Communi cati ons, Pi ramal Heal thcare Ltd. sai d, At Pi ramal Heal thcare, propelled by our core val ues of Knowl edge, Action and Care, w e are devoted to maki ng a real di fference to our consumers' lives by enabli ng i nformed choices. i-pill magni fies the i ndomitabl e spirit of the new Indi an w oman w ho i s resili ent in the face of every adversi ty. It empow ers Indi an women to remai n in control of their future without resorti ng to emoti onal ly and medi cal ly stressful al ternati ves like abortion."

Commenti ng on the sal e of i -pill, Mr. Amar Lull a , Joint Managi ng Di rector, Ci pl a Ltd. sai d, I n 2007, we had created i -pil l w hi ch is currentl y Indi a 's No. 1 OTC emergency contracepti ve brand. Our deci sion to di vest the brand i s driven by our current domesti c product portfoli o focused on prescri ption drugs. We are pleased that another Indi an heal thcare company with a strong OTC portfolio has bought the brand and are confi dent that Pi ramal Heal thcare will successfull y accel erate the future grow th of the brand.

i -pill i s an emergency contracepti ve pi ll (ECP) used to prevent unpl anned pregnancy and i s availabl e over the counter at l ocal chemi sts. It is not an aborti on pi ll. i -pill contai ns Levonorgestrel, a progestogen w hi ch hel ps prevent unwanted preg nanci es if taken withi n 72 hours of unprotected sex. "i -pill has no long term or seri ous side effects and i s safe to use for almost al l women except those w ho are al l ergic to Levonorgestrel.

i -pill has been i nstrumental i n buil di ng aw areness about the emergency contracepti ve pi ll category in Indi a .

The OTC market i n Indi a i s esti mated to be around US $1.8 bi llion and i s growi ng annuall y at 18%. Pi ramal Heal thcare has been an acti ve pl ayer i n the OTC space i n the l ast few years with a strong di stribution reach coveri ng both chemi sts and general stores. Commenting on the OTC market, Mr. Ajay Pi ramal, Chai rman, Pi ramal Heal thcare Ltd. noted that, We bel i eve the OTC segment i s still i n i ts nascent stages i n Indi a and presents us wi th hi gh grow th opportuni ti es. In parti cul ar the ECP segment whi ch is approxi matel y a Rs 100 crores i ndustry and has grow n by 250% i n the l ast two years".

Kotak Investment Banki ng acted as the excl usi ve financi al advi sor to Ci pl a for thi s transaction. About Cipla Incorporated in 1935, Cipl a is the No. 1 pharmaceutical com pany in Indi a as per ORG-IMS. Cipla is exporti ng its products to over 170 countries worldwide. With approximately 150 Active Pharmaceutical Ingredients (APIs) and more than 1600 formulation products i n its portfol io, the Company offers a wi de range of products across all the major therapeuti c categori es. The Company owns and operates 19 manufacturing facili ties across Indi a . Cipla i s listed i n Indi a on the National Stock Exchange (Ticker: CIPLA) and Bombay Stock Exchange (Ti cker: 500087)

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Thursday, 12 November 2009

Ci pla launches generic drug to treat H1N1 Business Standard Reporter/Mumbai

Indi an drug major Ci pla has l aunched generi c versi ons of anti -fl u drugs oseltami vir and zanami vi r i n the local market to treat the H1N 1 i nfl uenza, which i s spreadi ng across the gl obe and i n Indi a.

Ci pl a wi ll brand osel tami vi r i n the l ocal market as Anti fl u and zanami vir as Virenza. Antifl u wi ll cost Rs 475 for 10 capsul es, i n line wi th the pri ce of competi ng products in the market. Vi renza an i nhal ed drug wi ll cost Rs 800, w hi ch i ncl udes the pri ce for an i nhal ati on device.

Ci pl a's Anti flu is a copycat versi on of Swiss mul ti -national Hoffmann-La Roche's Tami fl u and Vi renza is the copy of Gl axoSmithKl i ne's Rel enza. Both drugs, used globally to treat the ongoi ng H1N1 pandemi c, l ack patent protecti on i n Indi a as these are pre-1995 i nnovati ons. Such i nnovations are not granted patents i n Indi a, accordi ng to the product patent regi me i ntroduced in the country si nce 2005.

Dr Y K Hami ed, chai rman and managi ng di rector of Cipla, sai d hi s company was equi pped to make 2 mil lion doses of osel tami vir a month, i n case of any eventuali ty. Already 450 peopl e have di ed of H1N1 i n Indi a and the wi nter season may cause further spread of the vi rus, he sai d.

Now the US i s faci ng a shortage of oseltami vi r and w e have i nformed our readi ness to suppl y the drug if needed. We make about 20 drugs in the anti -viral segment and are among the gl obal l eaders i n thi s category, sai d the Ci pl a chi ef, who revol utioni sed HIV/AIDS treatment gl obal ly by selli ng generi c drug cocktail s at l ess than a $1 per day.

Both drugs have p atent protecti on i n many devel oped countri es, incl udi ng the US and Europe. Hyderabadbased Hetero i s the onl y suppli er li censed by Roche to market osel tami vir i n Indi a under the brand name Fl uvi r.

On August 28, the Indi an government had all owed restricted retail sal e of the drug under Schedul es X category of the Drugs and Cosmeti cs Act, si milar to the sal e of narcoti cs drugs. Six Indi an compani es Ranb axy, Ci pl a, Strides Acrol ab, Hetero, Hetco and Roche were all owed to manufacture and sel l the drug. The government has al so stockpi led the drug from these manufacturers for suppl y through government channel s.

Two months ago, Natco Pharma had l aunched i ts version Natfl u i n the Indi an market at a pri ce of Rs 475 for a bottl e of 10 capsul es.

In 2005, w e had stockpiled about 2.5 tonnes of osel tami vir but there was no demand and about $15-20 million worth products had just pil ed up as i nventory, sai d Hami ed.

Ci pl a has so far exported about $10 million w orth of Anti flu to countri es i n Lati n Ameri ca, Afri ca, South-East Asi a and West Asi a, where the drug l acks patent protecti on.

Countri es wi th patent protecti on for these drugs can al so al low generi c pl ayers to manufacture and market i t, i nvoki ng compulsory li cence provi sions of the patent rul es, whi ch all ow breaki ng of patent rul es duri ng emergency, sai d Hami ed.

Shortage or monopol y of any drug will cause pani c among peopl e duri ng such pandemi c attacks, he added.

Hami ed has suggested that governments shoul d encourag e stockpili ng of shiki mi c acid, whi ch i s extracted from the Chi nese Star Ani se' and i s used as a base materi al for production of osel tami vi r through a 14-step chemi cal process, instead of stockpili ng the finished drug.

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Fri day, 25 September 2009

Pharmaceuticals Export Promotion Council Awards

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Press Trust of Indi a / Wednesday, 15 Jul y 2009

Ci pla FY 09 net up 10% at Rs 771 cr

Drug maker Ci pl a today reported a growth of 10 per cent in i ts consolidated net profi t for the fi nancial year ended March 31 to Rs 771.02 crore. The company had a consoli dated net profit of Rs 701.04 crore duri ng the 2007-08 fi nanci al year, Ci pla sai d i n a fi li ng to the Bombay Stock Exchange (BSE).

The consolidated total i ncome of pharmaceuti cal fi rm rose to Rs 5,326. 04 crore i n the l atest fi scal from Rs 4282.92 crore of a year earl ier.

The company has decl ared a di vidend of Rs 2 per share for the year 2008-2009.

On a stand al one basi s, Ci pl a posted a net profit of Rs 776.82 crore duri ng FY'09, an 11 per cent ri se compared to Rs 701.43 crore of FY'08.

Shares of Ci pl a today cl osed at Rs 272.15, al most fl at from i ts previous cl ose on the BSE.

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The Ti mes Of Indi a / Tuesday, 23 June 2009

Pharma market grows 10% in May Rupali Mukherjee, TNN

New Del hi : The domestic pharma retail market posted a heal thy growth of 10% i n May over the previous month. The pharma market regi stered a strong growth over the fi rst three months, January to March growi ng doubl e digi t. The grow th seems to have di pped sl ightl y duri ng two months Apri l and May to a li ttl e over 10% 10. 1 and 10.2% respecti vel y.

On a movi ng annual total basi s (Apri l'08 to May' 09), the organi zed pharma retai l market grew by 10.4% to Rs 36, 048 crore, whi ch w as slightly hi gher than the previ ous month's val ue of Rs 35,675 crore, accordi ng to consul ting company, ORG-IMS.

The market w as val ued at Rs 3,104.12 crore duri ng May, sli ghtl y lower than previ ous month's fi gure of Rs 3,146 crore. Duri ng the month, there w as little change i n the top ranki ngs of compani es. Ci pla occupi ed the top slot i n terms of market share, foll ow ed by Ranbaxy and Gl axoSmithKli ne on the thi rd positi on. Pi ramal Heal thcare was ranked fourth, fol lowed by Zydus Cadil a whi ch moved to the fifth sl ot. Zydus di spl aced Sun Pharma, which had moved to the fi fth posi tion i n April.

For some ti me now, Ci pl a has been domi nati ng the top slot followed by Ranbaxy and GSK i n terms of market shares.

Al so, there were some movements as far as the top 20 compani es w ere concerned wi th Dr Reddy' s Labs, Wockhardt-Meri nd and Emcure gai ni ng one rank each, to move up to rank 11, 14 and 16 posi tions respecti vel y, accordi ng to ORG-IMS.

Amongst medi cine brands, pai n kil ler drug Voveran mai ntai ned i ts top posi tion. Iron suppl ement Dexorange and l ipi d l ow eri ng medi cine, Strovas l eaped three ranks and jumped to rank fi ve and 20 respecti vel y. Oral rehydrati on sal t El ectral, pai n kil ler Spasmo -proxyvon and Asthal in (for managi ng asthma) were the hi ghest gai ners, movi ng four ranks each to ni ne, 15 and 16 posi tions respecti vel y.

Among the top 20 products, anti bioti c drug Taxi m, heal th suppl ement Li v-52, anti biotic Mox, Taxi m-O, gai ned one rank each and moved up to ranks ei ght, 11, 13, and 17 respecti vel y. Aciloc gai ned seven ranks and entered the top 20 list at rank 18 duri ng May.

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CNBC-TV18 / Tuesday, 12 June 2009

Swine flu declared a 'pandemic', first in 41 years

The W orl d Heal th Organi zati on (WHO) has decl ared Swine Fl u a 'pandemi c'. Swi ne Fl u has thus become the fi rst global pandemi c i n 41 years. Offi ci al reports say there are 28,000 cases of Swi ne Fl u gl oball y.

Amar Lul l a, Joi nt MD, Ci pl a , sai d Indi a needs to have adequate stocks of drugs li ke Osel tami vir and Zanami vi r to fi ght thi s pandemi c.

Here is a verbatim transcript of the exclusive interview with Amar Lull a on CNBC-TV18. Also see the

accompanyi ng video.

Q: The fact that the WHO (World Health Organisation) has now decl ared the Swine Flu a global pandemic, what does this mean for somebody like you?

A: It j ust means that w e need to be prepared. I thi nk more than us i t is important that the country i s prepared to face thi s eventual ity.

Q: Has the WHO or any other government got in touch with Cipla for Tamiflu?

A: Yes, there have been vari ous Lati n Ameri can countri es that have been i n touch with us and have been procuri ng Osel tami vir from us.

Q: How does it i mpact the pharma industry as well materially? Is there a race on now to perhaps get a Swine Flu vacci ne goi ng?

A: Yes, that would be the objecti ve. Ul timatel y, that woul d be the way forward. But ri ght now i t i s still very earl y to have the vacci ne. So, we need the treatment, we need Osel tami vi r, and need Zanami vi r. These drugs shoul d be adequatel y stocked.

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Indi a Knowl edge@Wharton / Thursday, 07 May 2009

Ci pla Pharmaceuti cals' Yusuf Hamied: 'I Am Not Agai nst Patents ... I Am Against Monopolies'

Many basi c, life-saving medi cations remai n unaffordabl e in low - and middl e-income countri es. Spurred on by that fact, Yusuf Hamied, chairman and managing di rector of Cipla Pharmaceuticals, has steered his enterprise to the forefront of global pharmaceutical development by manufact uri ng l ow-cost drugs for diseases like AIDS, diabetes and arthriti s, among others.

Cipla has faced chall enges in India and abroad from multinational pharmaceutical companies l ooki ng to protect their patents on parti cul ar medi cations, including anti retrovi ral drugs used to combat HIV infections in countri es like South Afri ca, where access i s severel y limi ted by the annual per-person cost of US$10,000 to US$15,000. Most recently, the Delhi high court aw arded Cipla the ri ght to conti nue selling a low-cost generi c equi val ent of the lung cancer drug Tarceva followi ng a patent-infri ngement suit by the drug' s manufacturer, Swiss pharmaceuti cal company Hoffman-LaRoche.

Born i n Lithuania but rai sed in Mumbai, Hamied received a PhD in chemistry from Chri st's College, Cambri dge Uni versi ty . In 2005, the Indian government gave hi m the Padma Bhushan aw ard, one of the country' s highest civilian honors.

In an interview with India Knowledge@Wharton, Hami ed descri bes hi s company's skirmi shes with multi nati onals looki ng to protect their patents on particular medications and explains w hy rul es governi ng intell ectual property ri ghts i n industrialized nations should not appl y to poorer countries.

India K nowledge@Wharton: What are the key l essons to be l earned by Indi an l awmakers from the
controversy i n AIDS-ravaged South Afri ca ?

Yusuf Hamied: The controversy i n AIDS-ravaged South Afri ca gi ves you a glimpse of w hat' s i n store i n a
monopol y. Indi a must seri ousl y exami ne i ts Intell ectual Property Ri ghts (IPR) posi tion and see how best TRIPS (Trade Rel ated Intellectual Property Ri ghts) can be i nterpreted, as IPR l aws are national l aw s. Indi a shoul d cull the best poi nts from vari ous laws to sui t her future needs. F or exampl e, Ameri can patent law s i nclude the Bol ar Provisi on, so that generi c compani es can have products ready for sal e as soon as a patent expi res. Compul sory li censi ng i s val i d under TRIPS and can be i nvoked w hen there i s a nati onal emergency. But di seases li ke mal aria, tubercul osi s and l eprosy are permanent, perpetual and even perenni al emergenci es i n countri es li ke Indi a, and I' d say that we need a system of automati c license of right for a fixed royal ty to the patent hol der (typi call y, about 2% to 4% of net sal es).

In fact, many of these i ssues were raised i n the I.K. Gujral Commi ttee Report i n 1993. The commi ttee was of the opi ni on that Indi a shoul d i nsist on automati c licensi ng i n certai n circumstances, besi des recogni zi ng the need that countri es at different stages of devel opment need to be treated di fferentl y.

India K nowledge@Wharton: Are you suggesti ng that Indi a reconsi der TRIPS itsel f? Hamied: I'd suggest a "TRIPS north" and a "TRIPS south, " where the north compri ses 600 million peopl e i n
the devel oped w orld whil e the south compri ses the 3 billion peopl e of the Thi rd Worl d . The rul es of industri al nati ons shoul d not necessaril y appl y to poorer nations. Ninety percent of the profits of multi nati onals are made i n the north and not the south, and that's w hat consti tutes the R&D component [for these compani es]. In fact, I woul d go so far as to say that i f TRIPS i s not changed, Indi a and other li ke-mi nded countries shoul d wal k out of the WTO and form the TWTO (Thi rd World Trade Organi zati on).

India K nowledge@Wharton: The W TO supports l egal protecti on of i ntellectual property rights of

mul ti nati onal pharmaceuti cal patents, as does the U.S. government, which i s strongl y lobbi ed by the mul ti nati onal pharma i ndustry. Then we have the UN, w hi ch i s slow when i t comes to fighti ng for the havenots to ensure that they have access to reasonabl y priced generi c medi cati on. On the other hand, we see Worl d Heal th Organi zation endorsi ng your generi c drugs for qual ity and approvi ng processes used i n generi c factori es. Where do you stand i n thi s difficul t situation?

Hamied: Onl y once a patent expi res i n a parti cul ar country can that product be manufact ured i n the country.
"Generi c" i s "post-patent" -- or, by extensi on, off patent, and therefore non-monopoli stic. Thi s questi on of monopol y of drugs i n the future -- if the Ameri cans, Europeans and Bi g Pharma get thei r way -- coul d be a di saster for the thi rd worl d.

India K nowledge@Wharton: Wi th the re-i ntroduction of patent ri ghts i n 2005 i n Indi a , what happened
to the compani es that sprouted up after 1972, w hen generi c copi es were l egalized? What happened to Ci pl a's producti on of generic drugs? Di d i t come to a grindi ng hal t? If you are still produci ng, is i t now illegal ?

Hamied: No. The cut-off poi nt is 1995: It is l egal to replicate any drugs i nvented and patented i n I ndi a pre1995, but post-1995 i t is not permitted. However, the drugs i nvented after 1995 w ill onl y enter the market around 2012-2015, w hi ch i s when we will begi n to feel the pi nch. Currentl y, i n the Third Worl d , older drugs don' t di e. They coexi st with newer ones. As patents expi re, w e acqui re the l egal ri ght to manufacture offpatent drugs, maki ng i t a conti nuous process.

India K nowledge@Wharton: There have been a number of new judgments rel ated to i ntell ectual
property protecti on that Ci pl a contri buted to, such as your wi n over Roche that ensured an uni nterrupted suppl y i n Indi a of a low -cost medi cine for treati ng l ung cancer. What do you thi nk about the country's evol vi ng IP legi slati on?

Hamied: I'm told that the judges and staff at the patent offi ce have been trai ned by Ameri can offici al s,

whi ch means that they wil l be bli nkered. But I am particularl y i nterested i n these questions: How is it that so many heal th care patents have been granted i n such a short ti me peri od? Are the patents properl y examined? Just because a p atent i s granted i n Europe or Ameri ca , does that mean i t passes the Indi an Patent Law , whi ch i s different?

These questi ons are of parti cul ar rel evance to the new cl ause 3d i n the Indi an Patent Act (whi ch refuses patent protecti on to new forms, uses or mi nor modifi cations of exi sting drugs unl ess they di ffer si gni ficantl y wi th regard to efficacy). Approxi matel y 7,000 patents w ere filed before clause 3d [came i nto exi stence]. In the presence of thi s new cl ause, 60% of these patents are not vali d. Why aren't they vol untaril y withdrawn? It is onl y fai r that those who fil ed for these patents revi se them.

India K nowledge@Wharton: Why do you thi nk the Government i s bri nging changes to the IP regi me? Hamied: If you ask the Indi an government, they have a ready answ er: "We can' t upset the i nternati onal
communi ty." I tol d them, "But gentl emen, the patent l aw is a national l aw. How are you upsetti ng the i nternati onal communi ty when Indi a 's overal l i nternati onal trade i s 0.8% of w orl d trade? We'll reach 1% by 2010. What i s the bi g deal ? Who i s benefi tting?" Whil e the w orl d [pharmaceuti cal] trade market i s pegged at US$700 billion, Indi a stands at a mere US$7 billion.... I am not agai nst patents, but Indi a cannot afford them. I am agai nst monopoli es.

India K nowledge@Wharton: Can drugs from Bi g Pharma reach all of Indi a ? Hamied: They can onl y do so i n an aura of monopoly. That i s why [mul ti national s] gave up Indi a i n 1972.
We di dn't reach this positi on overni ght. It took 10 to 20 years for Indi an compani es to grow. Ri ght now, w e are i n a period of stabilization. The mul ti nationals wi ll stand to gai n w hen we start losi ng out. The cutoff date is 2012 or 2015, when patents for ol der drugs di e and new er drugs, w hi ch doctors will want to use, enter the market. And that is when I will say that the Indi an government has commi tted sel ecti ve genoci de in I ndi a .

India K nowledge@Wharton: In your opi ni on, how does Indi a bal ance the ri ghts of a patent hol der whil e
provi di ng affordabl e heal th care for all ?

Hamied: The fact i s that heal th care i n Indi a has always been i n a state of perpetual crisis. The di sease
profil e is fri ghteni ng: 80 mil lion cardi ac pati ents, 80 mil lion affected wi th mental ill ness, 60 million di abeti cs, 50 million asthmati cs, 50 million hepati ti s B cases, and one i n three Indi ans is a l atent carri er of TB. The Worl d Bank has sai d that Indi a wi ll have 35 million HIV cases by 2015, approxi matel y hal f of al l the AIDS cases i n the world. Gi ven these facts, the patent regi me in thi s country shoul d be so devi sed that utmost pri ority is given to secure the peopl e's ri ght to access affordabl e, quali ty heal th care without monopoly. Thi s can be achi eved by an autom ati c li cense of ri ght with a sui tabl e royal ty payment on net sal es to the i nnovator. Even a developed country li ke Canada followed thi s poli cy from 1969 to 1992, under the Canadi an bill S-91.

Apart from thi s, if at all, the government shoul d onl y allow patents filed after January 1, 2005, [to be consi dered] product patents. (As a member of the WTO, Indi a set a goal to make i ts patent l egisl ati on TRIPScompli ant by January, 2005.) Al so, probl ems such as "evergreeni ng" (when i nnovator pharmaceuti cal compani es abuse the patent and regul atory systems to delay the l egi ti mate entry of generi c competi tion) and fri vol ous patenti ng shoul d be careful ly revi ewed. Compul sory licensi ng provisi ons have to be favorabl e for the i ndigenous i ndustry, as also patenti ng by Indi ans i nternational ly. Importati on of a patented product alone shoul d not be consi dered as operati ve of a working patent.

We need to take a cl oser l ook as to w hat is best for Indi a . One cannot have the same l aws for 600 million peopl e i n the devel oped w orld and 3 bil li on peopl e in the Thi rd World . Gl obali zati on of heal th care does not

mean that the si ck and needy are deni ed access to drugs at affordabl e pri ces.

India K nowledge@Wharton: How do you expl ai n this to poli tici ans and pol icy makers? Hamied: I try. I'll gi ve you an exampl e of w hat happened to me. All over the worl d, w e [offer] a certai n
medi cine that stops AIDS transmi ssion from mother to child, free of cost. I show ed i t to an Indi an poli tici an several years ago. He asked me i f I gi ve thi s drug free of cost, and I sai d "yes." Do you know w hat hi s response was? "You must have an ul terior moti ve. " I l aughed and sai d, "Yes, I do have an ul teri or motive. I want to do some good before I di e. I am not goi ng to take any of thi s [with me] w hen I di e!"

You see the mi ndset?

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TopNews - Noi da, Uttar Pradesh, Indi a / Wednesday, 06 May 2009

Ci pla Gets Tentative USFDA Approval Shilpa Mahapatre

Major Indi an pharma fi rm Ci pl a has noti fied that i t has secured tentati ve approval from the Uni ted States Food and Drug Admi nistration (USFDA) for i ts tenofovi r di soproxil fumarate tabl ets.

In a disclosure to the Bombay Stock Exchange, the company sai d that Tenofovi r di soproxil fumarate tabl ets are i ndicated for use in combination wi th other anti retroviral agents.

The drugs are prescri bed for the treatment of HIV-1 i nfecti on i n adul ts.

The company has recei ved tentati ve approval to sell the drug i n tabl et form i n dosages of 300 milligram under the Presi dent' s Emergency Pl an for AIDS Rel ief program.

It can be recalled that Tenofovi r di soproxil fumarate tabl ets are the generi c versi on of Gilead Sci ences Inc.' s (GILD) truvada.

The Indi an company i s know n for produci ng l ow -cost anti -AIDS drugs for HIV-posi ti ve pati ents in devel opi ng countri es.

Moreover, Ci pla makes drugs to treat cardi ovascul ar di sease, arthri tis, di abetes, w ei ght control , depressi on and many other heal th condi ti ons. The products produced by the company are di stri buted i n nearl y 200 countri es of the world.

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ET Bureau / Saturday, 02 May 2009

St gives thumbs down to cos with forei gn ops Kiran Kabtta Somvanshi

Indi an compani es that had ventured abroad ri di ng on a wave of global isation and cross-border M&As are fi ndi ng life tough abroad. The prized

forei gn assets are now turni ng out to be millstone around the neck, pul li ng down the consoli dated fi nances even i f domesti c operati ons are profi tabl e.

The poi nt has not been mi ssed on the stock market and the compani es with foreign exposure have been hi t hardest i n the market mel tdow n. In contrast, domesti c-market focused compani es are goi ng strong as Indi an economy conti nues to grow despite a gl obal recession.

The contrast comes cl earl y w hen we compare Tata Steel and SAIL. In the past 12 months, stock pri ce of Tata Steel i s down nearl y 75% while SAIL's share pri ce has kept pace wi th the benchmark i ndi ces and i s down j ust 35%. The market has puni shed Tata Steel despi te it bei ng a more cost-effi ci ent steel producer. W hat' s pul ling dow n Tata Steel i s Corus, whi ch it acqui red for $13.7 billion to become worl d's si xth l argest steel maker.

The story i s si mil ar i n case of Nalco and Hi ndal co. Though the l atter i s Indi a's l argest and one of the w orld's lowest cost al umi ni um producers, i ts shares have been one of worst performers i n the sector. Hi ndal co is bei ng wei ghed down by the market concerns regardi ng the fi nanci al heal th of its American subsi di ary Noveli s.

Compani es who have set up operati ons abroad have seen consi derabl e erosion i n val ue as agai nst companies wi th predomi nant Indi an operations. For i nstance, Ci pla is now twi ce more val uabl e than Ranb axy and Dr Reddy's Laboratori es, despi te i t bei ng the smallest of the three. And thi s i s not without meri t. Cipl a i s now one of Indi a' s most profi tabl e drug makers.

What has worked i n its favour i s its steadfast strategy to serve the domesti c market and use Indi a as a l ow cost manufacturi ng hub and stay away from cross-border M&A. In contrast, Dr Reddy's and Ranb axy have aggressi vel y expanded overseas throug h a seri es of acqui sitions.

The story i s same i n the auto sector, where domesti c-market focused compani es such as Maruti Suzuki, Hero Honda and Bosch are doi ng much better than thei r counterparts wi th deep connecti ons to rest of the w orl d.

The contrast i s becomi ng even more evi dent as compani es report thei r l atest quarterl y numbers. Forei gn operati ons are not onl y hit by a global recessi on, but they al so expose Indi an owners to forei gn currency ri sk and ri si ng cost of servi ci ng the acqui sition cost. Reli ance Industri es, for i nstance, made a provi sion of Rs 370 crore towards possi bl e dimi nution i n val ue of overseas subsi di ari es.

Praj Industri es also has made a si milar type of w rite-off of Rs 11.2 crore. Thi s i s for the fi rst ti me that these compani es have made such provi sions. Ranbaxy i s faci ng losses i n thei r European busi ness and has wi tnessed si gni fi cant drop i n growth. Mari co has al so reported poor performance i n Egypti an operati ons.

In such scenario, compani es have no opti on but to undertake restructuri ng of thei r overseas operati ons. But thi s i s costly and ti me-consumi ng exercise. Besi des, it may defl ect compani es' attenti on from the domestic market, whi ch may prove costl y i n the l ong-run.

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ET Bureau / Fri day, 01 May 2009

New Delhi rejects A merican firm's plea to patent Hepatitis B drug Khomba Singh

NEW DELHI: The Del hi Patent Offi ce has rejected Ameri can company Gi l ead Sci ences' pl ea to patent i ts Hepati ti s B drug adefovi r di pivoxil sol d

under the brand name Hepsera. Indi a's l argest drugmaker Ranbaxy had fil ed a pre-grant opposi ti on agai nst Gi l ead's patent appli cation sayi ng that i t is not a new drug and l acked i nventi ons.

Thi s is Gil ead's second drug to be rejected by the Del hi Patent office i n the l ast two months. Last month, the same patent office turned down the company's patent appl ication for i ts popul ar anti flu drug Tami flu as the patent offi ce found meri t i n Ci pl a' s opposition that the drug l acked i nventi on to be gi ven a patent under Indi an patent l aw s.

Hepsera i s also used by HIV pati ents infected wi th Hepati tis B. As per Gil ead's websi te, Hepsera i s used to treat chroni c infecti on wi th hepati tis B virus (HBV) i n adul ts. It stop Hepati tis B vi rus (HBV) from mul ti pl yi ng by bl ocki ng HBV DNA pol ymerase, an enzyme that i s necessary for the repl icati on of the virus i n the body.

A patent grant to Gilead for Hepsera w oul d have prevented any other generi c company from maki ng a low cost version of the drug wi thout the consent of the patent-hol der for the next two decades. The drug has an annual sal es of around $285 mil lion.

In its order l ast month, the Del hi patent office's assistant controller of patents & desi gns N R Meera refused to grant patent for Hepsera. Mumbai -based patent consul tancy fi rm IP Feathers' Varun Chhonkar w ho revi ewed the deci sion sai d the patent offi ce found Gliead's applicati on l acki ng i nventi ve step and fai led to provi de comparati ve data with respect to known substance to prove i mprovement enhanced thereup ati c effi cacy.

Gi l ead has reportedl y sai d it wi ll contest the rejecti on of i ts patent appli cation for its other drug, Tamifl u. The rejecti on came as a ti mel y booster for generi c drugmakers ahead of the global Swi ne fl u outbreak. Ci pla and other generi c compani es can now l egal ly manufacture and sell thei r generi c drug i n Indi a and other countri es where Roche does not hol d patent.

Swiss company Roche has the marketi ng li cense for the drug i n Indi a and as per Gil ead's w ebsi te it earned around $33 mil lion globally for the quarter ended March 31, as royal ties for Tami fl u from Roche.

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moneycontrol.com / Monday, 27 April 2009

Ci pla wins Erlotini b case against Roche

Ci pl a touched a 52-week hi gh of Rs 247.50. At 10 am, the share w as quoti ng at Rs 247, up Rs 6.70, or 2.79% on the NSE.

The company has won Erloti ni b case agai nst Roche i n Del hi HC. The Roche' s appeal has di smissed wi th Rs 5 l akh penal ty, reports CNBC-TV18.

It w as tradi ng wi th vol umes of 104,410 shares. On Fri day the share cl osed up 3.94% or Rs 9.10 at Rs 240.30.

Share Price Movement During The Last 12 Months Period 3-Days 5-Days 7-Days Price 227.15 222.70 230.00 Latest Price 247.00 247.00 247.00 Gain/Loss (Rs.) 19. 85 24. 30 17. 00 % Gain/Loss 8.74 10. 91 7.39

15-Days 1-Month 3-Month 6-Month 9-Month 1-Year

227.20 203.30 191.10 160.10 231.70 226.60

247.00 247.00 247.00 247.00 247.00 247.00

19. 80 43. 70 55. 90 86. 90 15. 30 20. 40

8.71 21. 50 29. 25 54. 28 6.60 9.00

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The Hi ndu Busi ness Li ne / Saturday, 25 April 2009

Ci pla Q4 net profit up on better product-mix

Expects tough year ahead.

Our Bureau

Mumbai, April 24 Drug-maker Ci pl a Ltd sees the year ahead bei ng tough, as a resul t of i ntense generi c competi tion and the sl owdow n i n global markets. But the negati ve i mpact could be bl unted by the company's spread of exports across geographi es, besi des havi ng products i n several therapeuti c segments, sai d Cipl a's Chi ef Executi ve, Mr Amar Lull a.

Ci pl a's net profit for the quarter i ncreased on the back of a better product-mi x, he sai d. But the company al so saw a forex hit of Rs 10 crore i n the current quarter, agai nst Rs 25 crore i n the correspondi ng l ast quarter.

Ci pl a is unli kel y to be hi t by forex-rel ated acti vity, goi ng ahead, si nce i t has accounted for all such acti vi ty, provi ded there i s no major rupee-rel ated fl uctuati on, he sai d. There has been an i ncrease of 49 per cent i n other expendi ture (Rs 122 crore) on account of sal es expendi ture, forei gn exchange l oss and year-end provi sions, the company sai d.

Domesti c Sales

Ci pl a saw domesti c sal es grow by 16 per cent, whil e exports grew by 11 per cent, duri ng the quarter under revi ew. The company's exports of acti ve pharmaceutical ingredi ents, though, saw close to five per cent di p in

the quarter. Ci pl a will i ncreasi ngl y focus on formul ati ons that make for a more sustai nabl e segment, he sai d.

Materi al cost has decreased d uri ng the quarter mai nl y because of favourabl e exchange rate and changes in product mi x. Thi s i mpact i s also refl ected i n i ncreased operati ng margi ns, as compared to the previ ous year, si nce exports are booked at prevaili ng exchange rates, the company sai d.

The company posted a net profi t of Rs 767 crore for the year ended March 31, 2009, as compared to Rs 701 crore i n the correspondi ng peri od l ast year. Total i ncome increased from Rs 4,271 crore for the year ended March 31, 2008 to Rs 5,338 crore for the year ended March 31, 2009.

Ci pl a' s shares were up close to four per cent on the BSE, at Rs 239 on Fri day.

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The Ti mes Of Indi a / Monday, 02 March 2009

Pharma retail market grows 15%

NEW DELHI: The domesti c pharma retail market has started the year wi th a bang, recordi ng nearl y 15% growth i n January. The market had grow n by

nearl y 10% duri ng January-Decemb er 2008, and over 13% i n December al one.

There w as no major change i n ranki ngs of pharma compani es i n January i n terms of market share, with Cipl a garneri ng the l argest, fol lowed by Ranbaxy and Gl axoSmi thKli ne at third positi on, accordi ng to consul ti ng company, ORG-IMS. Pi ramal Heal thcare was ranked fourth, follow ed by Zydus Cadi l a at the fi fth slot in terms of market share.

Duri ng January, Pfi zer moved up two ranks to the 10th posi tion among compani es wi th the l argest retai l sales i n the market. Abbott (rank 12), Dr Reddy's Labs (rank 14), Intas Pharma (rank 18) and Mi cro Labs (rank 20) gai ned one rank each, as agai nst December l ast year.

The domestic retai l market val ued at Rs 2,908 crore i n January, has been recordi ng a growth for the l ast three consecuti ve months si nce November 2008, after a slight bli p i n October.

The val ue growth for 12-month peri od ended January (mo vi ng annual total basis) was 9.9%, whi ch i s al most the same as December' s grow th of 9.8% (as per December MAT). Industry experts poi nted out that pharmaceuti cal s and heal thcare are recessi on-proof sectors, and will keep growi ng at a steady pace over the next few months.

In January, pai n killer drug, Spasmo-Proxyvon was the hi ghest gai ner i n ranks, amongst the l argest selli ng drugs, movi ng up from the 24th slot i n December to the 18th. The other maj or gai ners are vi tami n suppl ement Revi tal , havi ng moved up from the 11th sl ot in December to seventh posi ti on i n January, and i ron suppl ement Dexorange, gai ni ng four ranks (rank 11 as per January ' 09). Zi netac used to treat pepti c ulcer

moved up three sl ots to the 14th posi tion, up from rank 17 i n December.

Among the therapeuti c areas, cardiovascul ar segment recorded a 14% grow th, whil e anti-i nfecti ve medi ci nes grew 10% duri ng the month.

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The Hi ndu Busi ness Li ne / Wednesday, 25 February 2009

Patents yes, but monopoly no

India needs to protect its national interests and not w orry about ruffling feathers internati onall y.

DR YUSUF K. HAMIED, CHAIRMAN, CIPLA

P. T. Jyothi Datta

It i s i n thi s room that Parvi nder and I started the IPA (Indi an Pharmaceuti cal Alliance), says the Ci pl a Chai rman, Dr Yusuf K. Hami ed, poi nti ng to hi s offi ce, where M. F. Hussai n pai nti ngs sit easy wi th stacks of papers on i ntell ectual property, the Doha debates and speeches crusadi ng agai nst monopolistic practi ces of drug compani es. We were i ndi genous compani es, coming together to j oi ntl y fi ght, he remi nisces.

Under the l eadershi p of its former chai rman, the l ate Parvi nder Si ngh, Ranbaxy had joi ned compani es such as Ci pl a and Dr Reddy's i n taki ng the generi c-drugs battl e right i nto the backyard of mul ti national compani es, by selli ng i nto devel oped and developi ng markets.

But al most a decade l ater, there has been no easi ng of chal lenges for generi c drug-makers, wi th the l atest weapon bei ng Intell ectual Property Ri ghts (IPR) and the hydra-headed manner i n w hich i t i s bei ng i nterpreted and i mpl emented, gl oball y and at home.

As a sci enti st, I believe i n patentsbut I do not bel ieve i n monopol y, he says, respondi ng to what the

generi c drugs i ndustry percei ves as covert global efforts to rai se obstacl es i n thei r way, i ncl udi ng equati ng generi cs or chemi cal ly simi lar medici nes to counterfei ts.

In the l ast three-odd months, Indi an generi c drug-makers Ind -Swift, Dr Reddy's and Ci pl a have had their medi cine consi gnments sei zed at Amsterdam, though these shi pments were just transi ti ng to South Ameri can desti nations. The export consi gnments were hel d on IPR i nvesti gati ons and the compani es invol ved have si nce taken back thei r consi gnments or abandoned them.

The sei zure of the export consi gnment was done usi ng a European Commi ssion regul ati on of 2003. And such an i nterpretati on of thi s rul e, five years after bei ng brought i nto force, w as agai n, a pl oy to retai n monopol y, says Dr Hami ed.

At home too, a cocktai l of IPR chall enges has onl y added to the woes of local compani es, he says, traci ng back to the buil d-up and amendment of the Indi an Patent Law i n 2005, after which the country started honouri ng product patents. Then came the more recent attempts i n the country to link the issue of patents (gi ven by the Patent Controll er's offi ce) wi th the marketi ng approval s on medi ci nes gi ven by the Drug Controll er General of Indi a's offi ce, an i ssue currentl y bei ng fought i n the courts here.

Frivolous patents

El aborati ng on hi s concerns of compani es trying to retai n monopol y, he expl ai ned that an amendment to the Indi an Patent Act had been i ntroduced through Section 3d essenti all y to stop the ever-greeni ng of patents.

Ever-greeni ng refers to the practi ce of drug compani es that are known to make smal l i ncremental changes to exi sting drug mol ecul es to extend the patent even as the ori gi nal 20-year protecti on expi res.

There w ere about 7,000 p atents pendi ng cl earance once the amended Patent Law came i nto effect. I am repeati ng thi s, agai n and agai n and agai n, that of those 7,000 patents, accordi ng to me, 5, 000 woul d be i n the 3d category of no novel ty, he says, addi ng that the observati on was based on exi sti ng pharma patents.

Novel ty sal ts, esters, pol ymorphs, etc., coul d be not eli gibl e for patents; moreover, some of these patents wi th mi nor vari ations are not legally patentabl e.

We are seei ng the same patent und er different applicati ons comi ng i n. My contenti on i s, of the patents that the mul ti nati onal s have put i nto Indi a and that do not quali fy under 3d or on novel ty, such as combi nations, they shoul d voluntarily withdraw. Not a si ngl e patent has been vol untari l y wi thdrawn (till ) today, he observes.

Out of bounds

Referri ng to the patent-rel ated li ti gation that Ci pl a i s i nvolved i n, he says, We do not like breaki ng l aws. Where we fel t we had a very strong case and a good case, w e have chal lenged. Where we have no case, l ike i n the thi rd and fourth generati ons ARVs (anti -retroviral drugs for AIDS), we have not chal l enged, he says.

Such an admi ssion shoul d have set off al arm bell s among the powers that be, comi ng from Ci pla. The Mumbai -based drug-maker had i n 2001 set the cat among st the pi geons w hen i t offered i ts generi c AIDS drugs at a fraction of the MNC pri ce i n the Afri can market, forci ng the bi gger compani es to sl ash pri ces.

Ei ght years l ater, Ci pla admi ts that the next generati on of AIDS-drugs are out of bounds for generi c drug-

makers, as they are product patent-protected.

The rami ficati ons of Dr Hami ed's admi ssion on next-generation AIDS drugs i s worryi ng, as i t i s not restricted to just thi s segment of medici nes or market. Indi an generic drug-makers suppl y medi ci nes across therapeuti c segments to several countri es i n the w orl d, and thi s coul d take a hi t, affecti ng not just the compani es, but pati ents as well .

A permanent compul sory l icensi ng (CL) system, w here generic compani es are all owed to make copi es of the i nnovator's medi ci ne, but on the payment of a royal ty of, say, four per cent of thei r sal es, is what Dr Hami ed suggests to break the i mpasse.

But whether thi s suggestion will have takers i n the Government or among other i nnovator compani es i s sti ll to be seen.

We were promised categori call y by the Government that product patents will onl y ki ck in p ost-2005. Not back-dated to 1995, he l aments. What i s w rong i s Indi a's defensi ve attitude. Why are we defendi ng all the ti me?, he asks, i n hi s characteri stic rhetorical styl e.

The EMR (excl usi ve marketi ng ri ghts), that w as thrust on us, was done retrospecti vely, he says. The rational e was that process patents filed from 1995 till 2000 coul d be converted i nto product-patents on EMRs. Worl d trade rul es do not allow patenti ng i n retrospect, he adds.

You cannot backdate. Some of the products that were i nvented i n thi s five-year peri od, we were w orki ng on, thi nki ng that these w ere process patents and not product patents, he says.

National, not international

Indi a needs to protect i ts nati onal interests and not w orry about ruffl i ng feathers i nternati onall y, he states emphati cal l y. When Indi a i s nowhere i n the human devel opment report, how are w e cl assifi ed as a developed country. Just because there are pockets i n Indi a that are super devel oped, doesn't make Indi a a shi ni ng country, he observes, campai gni ng for a w orkabl e CL system.

Thi rd worl d countri es i ncl udi ng Indi a cannot afford monopol y. I am repeati ng it to such an extent that peopl e say you have nothi ng el se to tal k about, he excl aims.

Di stanci ng the di scussion from hi s company and my newspaper, he says: I am sayi ng what is best for our country, i rrespective of Ci pl a, i rrespecti ve of everythi ng. And genui nel y, beli eve me. I have been sayi ng i t now for 50 years. Even i n 1961, before the patent laws were chang ed i n 1972, we had meeti ngs with the mul ti nati onal s I sai d, as a sci enti st, I bel ieve i n patents, I am not sayi ng no. But I do not beli eve in monopol y. I am wi lli ng to pay a royal ty.

Ci ting Canad a's CL system, he says, nobody objected to i t neither the Ameri cans nor the Europeans. Why can' t I ndi a have a si milar system, wi thout worryi ng about upsetti ng i nternati onal fri ends?

When peopl e cannot afford drugs, particul arl y anti -cancer drugs, at some ti me it w as the anti -AIDS drugs, onl y competi tion can hel p you. We are willi ng to pay royalty but do not stop us from manufacturi ng, he says.

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IRIS / Wednesday, 03 Decemb er 2008

Ci pla gets USFDA nod for Pami dronate disodium injection

Leadi ng drug maker, Ci pl a has recei ved fi nal approval from the US Food and Drug Admi ni strati on (USFDA) to market Pami dronate di sodi um i njecti on, in the strengths of 30 mg/vi al, 60 mg/vi al and 90 mg/ vi al .

Pami dronate di sodi um acts on bone to hel p regul ate blood cal ci um level s. I t is used to treat Paget`s di sease of bone and to treat hi gh bl ood cal ci um l evels.

The medi cati on i s al so been used i n the treatment of osteoporosis, to reduce bone pai n associ ated with certai n ill nesses and to treat bone l oss due to breast cancer.

Shares of the company decli ned Rs 2. 1, or 1.13%, to settle at Rs 183. The total vol ume of shares traded was 231,412 at the BSE (Wednesd ay).

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The Ti mes Of Indi a - New Del hi / Monday, 27 October 2008

Pharma holds steady, Cipl a pips Ranbaxy

Rupal i Mukherjee, TNN

Ami dst all the gloom confronti ng the economy, the pharma sector posted a robust growth of over 14% i n September, with Ci pl a emergi ng as leader i n the domesti c retail market with a market share of 5. 31% i n September, overtaki ng Ranbaxy.

Till Jul y thi s year, Ranbaxy had been l eadi ng wi th a 5.10% share of the market. In September, Ranbaxy ranked second g arneri ng a 5.11% share, whil e Gl axoSmi thKl ine occupi ed the thi rd sl ot with 4.47% market share. Pi ramal Heal thcare and Zyd us Cadil a were ranked fourth and fifth i n the domesti c market with shares of 3.75% and 3.59% respecti vel y.

The domestic pharma market posted a heal thy grow th of over 14% i n September, wi th the market val ued at Rs 33,605 crore, accordi ng to consul ti ng company, ORG IMS. The market had grow n by over 12% i n August. Pharma compani es are, how ever, not posting strong financi al results i n the second quarter due to other factors li ke input and over-head costs.

In September l ast year, the company ranki ngs w ere pretty much the same wi th Ci pl a leadi ng wi th a share of 5.09%, follow ed by Ranbaxy at 4. 90% and GS K at 4. 86%. Ci pl a has mai ntai ned the top slot in the market for the l ast two years.

On a movi ng annual total basi s i n September (12-month peri od ended September), maj or gai ners (in val ue terms) i ncl ude Ci pl a at 17.7%, Ranbaxy and Sun Pharma each at 17.6%, Lupi n at 20. 9% and Manki nd at 35. 4%. Overall, the pharma market grew by nearl y 13% on a MAT basi s i n September. Duri ng the month, the respi ratory segment has shown a heal thy growth of 14%, whi l e anti -i nfecti ves have recorded over 18% growth and cardi o-vascul ar drugs grew by 18%.

Unl i ke other sectors of the economy, the domesti c pharma market has been abl e to sustai n i ts growth over the past one year, with a CAGR of 15%. Chroni c therapy has consi stentl y i ncreased its contributi on to the

domesti c market wi th the share of acute segment consi derabl y shri nki ng over the past few years.

Wi thi n the chroni c segment, anti -di abetic drugs have shown the hi ghest val ue growth, fol lowed by cardi ac therapy d uri ng first hal f of the year. Anti -i nfective drugs have al so recorded a robust growth duri ng the period. Duri ng the six-month peri od, gastro-intesti nal therapy grossed the thi rd hi ghest val ue i n the market, foll ow ed by the respi ratory category.

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Busi ness Standard / Wednesday, 23 Jul y 2008

Ci pla: Active in overseas markets

Shobhana Subramanian & Varun Sharma

Stronger exports have hel ped boost revenues.

Dri ven by a smart 50 per cent grow th i n exports, the Rs 4,227 crore Ci pl a posted a top l ine grow th of nearl y 34 per cent i n the June 2008 quarter. The rel ati vely low base of Q1FY08 and a w eaker rupee notwi thstandi ng, thi s i s the fourth quarter of successi ve good growth recorded by the drug major.

Revenues from the home market i n June too have grown at a reasonabl y good 16 per cent and consequentl y the operati ng profit margi n expanded 360 basi s to 22 per cent, after adjusti ng for a forex loss of Rs 75 crore. The forex l oss, how ever, depressed the net profi t which rose just 17 per cent to Rs 140 crore.

Exports accounted for about hal f the fi rm's revenues of Rs 1207 crore l ast quarter. Anal ysts believe the hi gher sal es of acti ve pharmaceuti cal ingredi ents (API) coul d have i ncl uded suppli es to Teva, for a product sold excl usivel y in the US for a peri od of 180 days.

How ever, si nce such orders for suppli es duri ng periods of excl usivi ty do not recur too often, i t wi ll be sal es of formul ati ons that will determi ne the pace of Ci pl a' s exports i n subsequent quarters.

To sustai n a 25-30 per cent growth i n exports, however, the company will need to i ncrease the proportion of hi gh val ue products, li ke inhal ers, to regul ated markets. Cipl a, whi ch has l aunched asthma i nhal ers in Germany , Spai n and Portugal , i s looki ng to gai n a foothold i n the CFC-free i nhal er market.

Ci pl a has one of the strongest pi peli nes of generi cs among Indi an compani es.

The company has pursued a strategy of teami ng up with pl ayers overseas but does not get i nvolved i n patent li ti gation. It has recentl y roped i n a coupl e of partners i n the US and EU and pl ans to suppl y over 100 products to overseas markets i n the next few years.

The management beli eves the company's revenues can grow at 12-15 per cent i n FY09 and net profi ts at around 11-13 per cent.

The earni ngs per share i s esti mated to increase by about 20 per cent. In a w eak market, the pharma sector has been outperformi ng, with Ci pl a' s stock gai ni ng 7 per cent si nce the start of 2008. At the current pri ce of Rs. 238, the stock trades at a shade over 21 ti mes estimated FY09 earni ngs and i s a tad expensi ve.

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FDAnew s Drug Dai l y Bull eti n / Monday, 07 Jul y 2008

Ci pla Gets Thumbs Up for Generic HIV Drug

Indi an drugmaker Ci pl a has recei ved FDA approval for its HIV treatment zi dovudi ne oral soluti on 50 mg/5 mL, a generi c versi on of Gl axoSmi thKl i ne's Retrovi r.

The generi c Retrovi r appl ication was consi dered under the expedi ted revi ew provisions of the Presi dent' s Emergency Pl an for AIDS Relief (PEPFAR), a fi ve-year, $15 bil li on program ai med at combati ng HIV and other di seases i n 114 countri es incl udi ng 15 focus countri es pri mari ly i n Afri ca that Presi dent Bush announced i n 2003.

Zi dovudi ne i s a nucl eosi de reverse transcri ptase i nhi bitor intend ed to be used wi th other anti -retrovi ral agents to treat HIV-1 i nfecti on. The approval means no patents or excl usi vity prevent marketi ng the drug i n the U.S. The FDA often tentati vel y approves generi c versions of HIV drugs stil l under patent protecti on i n the U.S. so the generi cs may be eli gi ble for purchase under PEPFAR for use i n other countri es, the FDA sai d.

In February, Matrix Laboratori es received FDA approval for i ts generi c versi on of Retrovir 300-mg tabl ets.

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The Economi cs Times - New Del hi /Tuesday, 01 Jul y 2008

Ci pla gets patent for Nexium, Fosamax modified versions Khomba Singh, ET Bureau

Domesti c pharma major Ci pla has recei ved product patents for new forms of two blockbuster drugs Osemaprazol e and Al endronatefrom the Indi an authori ti es. Whil e the company' s patent on Osemaprazol e is a modi fi ed form of Astrazeneca's bl ockbuster drug market ed under the brand name Nexi um, Alendronate i s one of the best-selli ng drug of Merck sold under the brand name Fosamax. Nexi um, the world's second-l argest selling drug, has annual sal es of around $5.2 bil lion whi le Fosamax recorded sal es of $3 billion i n 2007. Fosamax' s patent exp ired i n February thi s year w hil e Nexi um's patent expi res in 2014.

When contacted, Ci pla joi nt MD Amar Lull a sai d, These are novel formul ations with a si gnifi cant thereupati c advantages than though i t uses the same chemi cal. We plan to l aunch the drug gl obal ly. The company has sought patents gl oball y through an appli cati on with the Patent Cooperati on Treaty (PCT) fi ling. If a company fi les a patent applicati on with the PCT, its applicati on will automati cally go to all TRIPS compliant countri es.

Ci pl a al so got the patent i n Indi a through i ts PCT appl ication. Accordi ng to the Indi an patent offi ce w ebsite, the Mumbai patent office granted i n April thi s year.

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The Economi c Times - New Del hi / Monday, 05 May 2008

Ci pla offers free know-how of essential drugs to PSUs

Khomba Singh, TNN

At a ti me when the government i s aggressi vel y imposing pri ce controls on essenti al drugs, Ci pl a has made an uncondi tional offer to share the know-how of maki ng all 354 essenti al drugs with the public sector drug manufacturers . Thi s follow s the pharma i ndustry's offer to sell the essenti al drugs at hal f its maxi mum retai l

pri ce (MRP) to the government subject to certai n condi tions.

Inci dental ly, Ci pl a, the l argest drug maker i n the country by sal es, i s not a part of the i ndustry associ ation whi ch made the separate offer to the authori ties. The firm i s will ing to share the know-how of maki ng these drugs wi thout any monetary consi derati on.

Ci pl a joi nt MD Amar Lull a told ET, We are willing to gi ve the technol ogical know -how to manufacture al l the 354 essenti al drugs to the government. He added that i nstead of bri ngi ng sel ecti ve pri ce control on brands and drugs, the government can manufacture these drugs in the state-owned uni ts and di stri bute i t through the pri mary heal thcare centres, medi cal hospital s and publ ic heal th i nstitutions at reasonabl e pri ces.

Accordi ng to hi m, this will not onl y meet the government's obj ective of provi ding essenti al medi ci nes at most reasonabl e pri ces, but also make the publi c sector organi sations economical l y vi abl e. Recentl y, industry body Indi an Pharmaceuti cal Alliance (IPA) offered to sell essenti al medi ci nes to the government at 50% of thei r MRP. They al so offered to fi nance a mechani sm to deliver these drugs at a concessi onal price by contri buti ng 0.25% of thei r total profi ts to the government, which could be a littl e l ess than Rs 10 crore. This woul d be i n addi tion to the corporate taxes the compani es pay to the exchequer. However, thi s offer was condi tional upon the government limiti ng the number of drugs under pri ce control to the exi sting 74 drugs.

Ci pl a markets 803 products i n the Rs 32,000-crore domesti c pharmaceuti cal market with 5.2% market share, accordi ng to the l atest monthl y sal es fi gures of ORG-IMS. The stri ng of such proposal s from drug makers comes i n the wake of a policy proposal by the government to extend the li st of drugs under pri ce control to all essenti al drugs.

How ever, a seni or i ndustry offi cial sai d that al l the proposal s woul d be irrel evant now as the mi ni stri es responsi ble for regul ati on and i mpl ementati on of drug pol ici es have to first sort out thei r i nternal differences. The two mi nistriesChemi cal & Fertili ser and Heal th which oversee drug fi rms have overl appi ng j uri sdiction.

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IRIS / Monday, 23 June 2008

Ci pla gets tentative approval from USFDA

Ci pl a has recei ved tentati ve approval from the US Food and Drug Admi ni stration (USFDA), for Lami vudi ne/Stavudi ne 30 mg/6 mg tabl ets and Lami vudi ne/Stavudi ne 60 mg/12 mg tabl ets for pedi atric use.

Lami vudi ne and stavudi ne are anti -viral drugs i ndi cated for use i n combi nati on with other anti retrovi ral agents for the treatment of HIV-1 i nfecti on.

Shares of the company cl osed down Rs 5.25, or 2.42%, at Rs 212. 1. The total volume of shares traded at the BSE w as 470,501 (Fri day).

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Busi ness Standard / Wednesday, 30 Apri l 2008

Ci pla: Overseas sales a booster

The drug fi rm has managed to grow its top line but operati ng margi ns remai n uni nspi ri ng.

The Rs 4,227 crore drug major Cipla has just seen its best ever quarter for international sales logging a growth of 23 per cent, driven by higher sales of international active pharmaceuticals ingredients and finished dosages. Cipla follows a strategy where it has partners in foreign markets to sell products. While this model limits aggressive profit expansion, since the company has to share profits with the overseas partner, it also involves a lower risk because expenses on marketing and allied costs are lower.
Unl i ke in recent quarters, where profi ts have been boosted by technology fees, the March 2008 quarter has seen the both domesti c and overseas busi nesses fare well , the former growi ng 13 per cent.

How ever, w hil e Ci pl a's domesti c sal es i n the March quarter w ere reasonabl y good, they were not as bri sk as those of pl ayers like Ranbaxy, whi ch posted an i ncrease of 16 per cent. Technol ogy fees too brought i n some money for Ci pl a, though l ess than i n previ ous quarters.

As a resul t, the company's operati ng profi t grew a fai rl y impressi ve 39 per cent to 203 crore, on a revenue growth of 19.6 per cent. However some of it was due to forei gn exchange gai ns rather than from the core busi ness.

So whil e Ci pl a may have manag ed to i mprove its operati ng profit margi n for the March 2008 quarter by 240 basi s poi nts to 18. 1 per cent, thi s was w el l below the company' s run rate for the past two years.

Besi des,the hi gher margi ns al so came off a l ow base. The street w as expecti ng much more and was di sappoi nted because the margi n expansi on was more the resul t of a much l ow er other expendi ture,w hi ch dropped nearl y 200 basi s poi nts as a percentage of sal es.

For the full year FY08, the company's operati ng profi t margi n fel l 290 basis poi nts to just over 20 per cent, because of hi gher raw materi al costs.

Moreover, the Ci pl a management expects to grow revenues by just about 12-15 per cent and mai ntai n margi ns i n FY09, numbers that have not enthused i ndustry watchers. Technology fees coul d be lower i n the comi ng years and forex gai ns are unli kel y to sustai n.

Anal ysts beli eve that earni ngs shoul d grow by about 10-14 per cent over the next coupl e of years. Other l arge generi c pl ayers like Ranbaxy saw operati ng profit margi ns improve by 290 basi s poi nts to 15 per cent in the March 2008 quarter.

The Ci pl a stock stayed fl at on Tuesday at around Rs 215. At thi s price the stock trades at 21.6 ti mes esti mated FY 09 earni ngs and are not cheap gi ven the ri sks i n the busi ness. Thus, the stock shoul d be a market performer goi ng forw ard.

Ranb axy, at the current pri ce of Rs 485, i s somew hat cheaper and trad es at under 21 ti mes esti mated CY 08 earni ngs, but that too i s expected to perform onl y in li ne wi th the broader market.

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The Econoni c Ti mes / Thursday, 20 March 2008

Ci pla scores a generic win over Roche

NEW DELHI: In w hat could be a shot i n the arm for Indi an generi c drug makers, the Del hi Hi gh Court on Wednesday rej ected an i njunction pl ea by Swiss drug major Roche to prevent Ci pla from manufacturi ng and selli ng generic versions of i ts patented anti -cancer drug Tarceva (Erl oti ni b) in Indi a.

The Indian drug makers generic version of Tarceva is priced at one-third the price of Tarceva and the HC rejected Roche appeal in public interest given the huge cost difference between the two drugs. However, this is only an interim order and HC will deliver its final judgement at the completion of the hearing. The court has also directed Cipla to keep a separate record of the sale of its generic anti-cancer drug as it will have to compensate Roche if the final verdict goes in favour of the Swiss company. Roche has applied for a stay (on the sale of the generic version of Tarceva). This is an interim order for not granting the stay, said Cipla joint MD Amar Lulla. The court has given an interim order which allows Cipla to market the generic copy of Tarceva. However, Cipla has been asked to keep the sales record of Tarceva separately, as Cipla would have to pay profit and damages cost to Roche if the Swiss company gets a favourable verdict after the complete hearing, an executive of an Indian drug maker who attended the hearing told ET. Ciplas share closed at Rs 206 on BSE, up 0.76% from Tuesdays close of Rs 204.45. Roche received patent for Tarceva in India last year, but has been subsequently facing post-grant patent opposition from Cipla and NGOs. Two months ago Cipla decided to market copy cat versions of the drug in India at Rs 1,600 per tablet one-third the cost of the patented drug. India, with a strong generic drug industry is fast becoming a battle ground between domestic drug makers and big pharma MNCs. With the Indian pharma industry set to grow annually at 13%, drug discovery companies are keen to establish a strong presence in India and protect their patents here. Domestic drug makers, on the other hand, want a liberal interpretation of the Indian patent laws and any favourable verdict strengthens their case. Watching closely from the sidelines are consumers who stand to gain if generic versions are introduced at lower costs. In addition, there are concerns in the government that once drugs are patented, the cost of medical treatment could become unaffordable and will prevent many patients from getting treatment of diseases such as HIV and cancer. Several Indian companies and NGOs have filed both pre-patent and post-patent oppositions to prevent global companies from getting patent protection. In the much publicised Glivec case, Novartis had unsuccessfully challenged section 3(d) of the Indian patent law which states that an innovation to a drug can only be granted patent if the new drug provides significant

therapeutic advantages. This decision had made Indian patent laws one of the most effective in the world. Another Indian drug maker, Hyderabad-based Natco has also sought compulsory licensing (CL) from the government for two cancer drugs Tarceva and Pfizers Sunitnib (Sutent). However, the decision on Ciplas case is not expected to have any bearing on Natcos plea for a CL.
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Busi ness Standard / Tuesday, 01 January 2008

Ci pla maintains No.1 position in Indian mkt

P B Jayakumar

Mumbai

Tops pharma ranki ngs with 5.42% market share, a head of Ranbaxy and GSK.

Ci pl a Laboratori es conti nues to be the l argest pharmaceutical company i n the domesti c market.

Ci pl a has topped the ORG-IMS ranki ngs for the month of November wi th a market share of 5. 42 per cent and sal es of Rs 146.32 crore, edgi ng out Ranbaxy whi ch stood at second posi tion wi th 5.09 per cent market share and Rs 137. 49 crore sal es.

In October, Ci pla topped with Rs 152. 04 crore sal es and a market share of 5.23 per cent, ahead of Ranbaxy, whi ch garnered Rs 148.40 crore sal es and 5.11 per cent market share, sai d sources.

Ci pl a overtook Ranbaxy and Gl axoSmithKli ne Indi a (GSK) to become the l argest pharmaceuti cal company i n the domesti c market for the fi rst ti me in May 2007.

Whil e GSK has mai ntai ned i ts number three posi ti on i n November, Zydus Cadil a (fourth), Al kem Laboratories (fi fth) and Sun Pharma (si xth) have moved one rank up from October.

Ni chol as Pi ramal, w hi ch faced raw materi al shortages for its l argest selli ng codi ene based formul ations, li ke Phensydyl , i n recent months, sli pped three positions to number seven i n November.

ORG-IMS, the l argest market i ntel li gence company i n India focusi ng on the heal thcare sector, tracks sal es of Indi an pharmas on a monthl y basis, through over 3, 000 stocki sts and 6, 000 doctors.

Indi an compani es are i ncreasi ng thei r share i n the domesti c market mai nl y due to i ncreased number of hi gh val ue new introducti ons, though the number of new i ntroductions have reduced recentl y, Shail esh Gadre, managi ng di rector, ORG-IMS, sai d i n an i ntervi ew l ast week.

Ranb axy' s grow th has been l argel y dri ven by new i ntroducti ons such as Voli x, an anti -di abetes drug l aunched i n January, Oframax-Forte and anti -asthmati c drug Synasma, whi ch it i n-li censed from Eurodrug Laboratori es.

Ranb axy' s anti bi otic Mox (amoxylli n), whi ch w as not among the top ten brands a year ago, has grow n to become the fourth l argest brand i n the domesti c market with monthl y sal es at Rs 9.8 crore in November, sources sai d.

Ci pl a's growth was powered by posi tive growth i n thei r exi sti ng portfolio, especi all y its respiratory products.

How ever, GSK has l ost market share mai nl y i n its mai n portfol ios such as anti - i nfecti ves, dermatologi cals and pai n management dr ugs whi ch grew slower than the market for these products, ORG-IMS sai d.

ORG-IMS named Al kem Laboratori es as the onl y company among the top ten for which both older products (10 per cent) and new i ntroducti ons (12 per cent) have contri buted si gnifi cantl y to val ue growth.

Our growth i n the domestic market i s mai nl y due to the grow th of our anti -infecti ve Taxi m and other brands such as Taxi mo, Cl avem, A to Z and Gemcal, expl ai ned Vinod Dua, head, domesti c busi ness of Al kem Laboratori es.

Al kem's Taxi m i s now the thi rd l argest brand i n the domesti c market with sal es of Rs 10.3 crore, behi nd Pfi zer' s cough syrup Corex (Rs 15.2 crore) and Novarti s Indi a's pai n kill er Voveron (Rs 11.6 crore).

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History
Khw aj a Abdul Hami ed, the founder of Ci pl a, was born on October 31, 1898. The fi re of nati onalism was ki ndl ed i n him when he was 15 as he wi tnessed a wanton act of col oni al hi ghhanded ness. The fi re was to bl aze wi thi n hi m ri ght through hi s li fe.

In college, he found Chemi stry fasci nati ng. He set sail for Europe i n 1924 and got admi ssion i n Berli n Uni versi ty as a research student of "The Technology of Bari um Compounds". He earned hi s doctorate three years l ater.

In October 1927, duri ng the l ong voyage from Europe to Indi a, he drew up great pl ans for the future. He wrote: "No modern i ndustry coul d have been possi ble wi thout the hel p of such centres of research work where men are engaged i n compelli ng nature to yi el d her secrets to the ruthl ess search of an i nvesti gati ng chemi st." His pl an found many supporters but no fi nanci ers. However, Dr Hami ed w as determi ned to bei ng "a small wheel , no matter how small , than be a cog i n a bi g wheel ."

Ci pla is born
In 1935, he set up The Chemi cal, I ndustri al & Pharmaceuti cal Laboratori es, whi ch came to be popul arl y know n as Ci pl a. He gave the company al l his patent and propri etary formul as for several drugs and medi cines, wi thout chargi ng any royal ty. On August 17, 1935, Ci pl a w as regi stered as a public limi ted company wi th an authori sed capi tal of Rs 6 l akhs.

The search for sui tabl e premi ses ended at 289, Bel lasis Road (the present corporate offi ce) where a small bung alow with a few rooms was taken on l ease for 20 years for Rs 350 a month.

Ci pl a was offi ciall y opened on September 22, 1937 w hen the fi rst products were ready for the market. The Sunday Stand ard w rote: "The bi rth of Ci pla whi ch w as l aunched i nto the world by Dr K A Hami ed will be a red l etter day i n the annal s of Bombay Industri es. The first city i n Indi a can now boast of a concern, w hich will supersede all existi ng fi rms i n the magni tude of i ts operations. Indi a has l agged behi nd i n the march of sci ence but she i s now awakeni ng from her l ethargy. The new company has mapp ed out an ambi ti ous programme and wi th i ntelligent di rection and skil lful producti on bids fai r to establish a great reputati on i n the East. "

Mahatma Gandhi visits Cipla

Mahatma Gandhi visits Cipla (July 4th 1939)

Jul y 4, 1939 w as a red-l etter day for Ci pla, when the Father of the Nati on, Mahatma Gandhi , honoured the factory wi th a visi t. He w as "del ighted to vi sit thi s Indi an enterpri se", he noted l ater. From the ti me Ci pla came to the ai d of the nation gaspi ng for essenti al medi cines duri ng the Second World War, the company has been among the l eaders i n the pharmaceuti cal i ndustry i n Indi a.

On October 31, 1939, the books showed an all time high loss of Rs 67,935. That was the l ast time the company ever recorded a defi cit.

In 1942, Dr Hami ed' s bl uepri nt for a techni cal i ndustri al research i nsti tute was accepted by the government and l ed to the bi rth of the Council of Sci entifi c and Industri al Research (CSIR), whi ch i s today the apex research body i n the country.

In 1944, the company bought the premi ses at Bombay Central and deci ded to put up a "fi rst cl ass modern pharmaceuti cal w orks and l aboratory. " It w as al so deci ded to acqui re l and and buil di ngs at Vi khroli. Wi th severe i mport restri cti ons hamperi ng production, the company deci ded to commence manufacturi ng the basi c chemi cal s requi red for pharmaceuti cal s.

In 1946, Ci pl a' s product for hypertensi on, Serpi noid , w as exported to the Ameri can Rol and Corporati on, to the tune of Rs 8 l akhs. Fi ve years l ater, the company entered i nto an agreement w ith a Swiss fi rm for manufacturi ng foromycene.

Dr Yusuf Hami ed, the founder' s son, returned wi th a doctorate i n chemi stry from Cambri dge and joined Ci pl a as an offi cer i n charge of research and devel opment i n 1960.

In 1961, the Vi khroli factory started manufacturi ng di osgeni n. This heral ded the manufacture of several steroi ds and hormones deri ved from di osgeni n.

The founder passes away

The w hol e of Ci pla was pl unged i nto gl oom on June 23, 1972 when Dr K A Hami ed passed away. The Free Press Journal mourned the death of a "true nati onali st, scienti st and great soul . The best homage we can pay to hi m is to contri bute our best i n the cause of self-reli ance and the prosperi ty of our country in our fi el ds of endeavour."

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Milestones
1935
Dr K A Hami ed sets up "The Chemi cal , Industri al and Pharmaceuti cal Laboratories Ltd." i n a rented bungal ow, at Bombay Central .

1941
As the Second Worl d War cuts off drug suppli es, the company starts produci ng fi ne chemi cal s, dedi cati ng all its faci lities for the w ar effort.

1952
Sets up fi rst research di vision for attai ni ng self-suffici ency i n technol ogical devel opment.

1960
Starts operati ons at second pl ant at Vi khroli, Mumbai, produci ng fine chemi cal s with speci al emphasi s on natural products.

1968
Ci pl a manufactures ampi ci lli n for the first ti me in the country.

1972
Starts Agri cul tural Research Di vision at Bangal ore, for scientifi c cul tivation of medi ci nal pl ants.

1976
Ci pl a l aunches medi cinal aerosols for asthma.

1980
Wi ns Chemexcil Award for Excel l ence for exports.

1982
Fourth factory begi ns operations at Patal ganga, Maharashtra.

1984
Devel ops anti -cancer drugs, vi nbl astine and vi ncri stine i n col laborati on with the Nati onal Chemi cal Laboratory, Pune. Wins Sir P C Ray Award for developi ng i nhouse technol ogy for i ndigenous manufacture of a number of basi c drugs.

1985
US FDA approves Ci pl a' s bul k drug manufact uri ng faci lities.

1988
Ci pl a wi ns Nati onal Award for Successful Commerci alisation of Publi cl y Funded R& D.

1991
Lauches etoposi de, a breakthrough i n cancer chemotherap y, i n associ ati on with Indi an Institute of Chemi cal Technol ogy.

The company pi oneers the manufacture of the anti retroviral drug, zi dovudi ne, i n technol ogical coll aborati on with Indi an Insti tute of Chemi cal Technol ogy, Hyderabad.

1994
Ci pl a's fifth factory begi ns commerci al producti on at Kurkumbh, Maharashtra.

1997
Launches transparent Rotahal er, the w orl d's fi rst such dry powder i nhal er devi ce now patented by Ci pl a i n Indi a and abroad. The palli ative cancer care centre set up by the Ci pl a Foundati on, begi ns offeri ng free servi ces at Warje, near Pune.

1998
Launches l ami vudi ne, becomi ng one of the few compani es i n the worl d to offer all three component drugs of retrovi ral combinati on therapy (zi dovudi ne and stavudi ne al ready l aunched).

1999
Launches Nevi rapi ne, anti retroviral drug, used to prevent the transmi ssi on of AIDS from mother to child.

2000
Ci pl a became the fi rst company, outsi de the USA and Europe to l aunch CFC-free i nhal ers ten years before the deadli ne to phase out use of CFC i n medi cinal products.

2002

Four state-of-the-art manufacturi ng facili ties set up in Goa i n a record time of l ess than twel ve months.

2003
Launches TIOVA (Ti otropium bromi de), a novel i nhal ed, l ong-acti ng anti chol inergi c bronchodi lator that i s empl oyed as a once-dail y mai ntenance treatment for pati ents with chroni c obstructi ve pul monary di sease (COPD).

Commi ssioned second phase of manufacturi ng operati ons at Goa.

2005
Set-up state-of-the-art faci lity for manufacture of formul ati ons at Baddi, Himachal Pradesh.

2007
Set-up state-of-the-art faci lity for manufacture of formul ati ons at Si kki m.

2010
Set up state-of-the-art faci lity for manufacture of formul ations at Indore.

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Board of Directors
Founder
Dr. K.A. Hami ed (1898-1972)

Chairman & Managing Director

Dr. Y.K. Hami ed

Joint Managing Director

Mr. M.K. Hami ed

Whol e-time Director

Mr. S. Radhakri shnan

Non-Executive Directors
Mr. V. C. Kotw al Dr. H. R. Manchanda Mr. M.R. Raghavan Mr. Ramesh Shroff Mr. Pankaj Patel Dr. Ranjan Pai