REGISTRATION CERTIFICATES ISSUED FOR THE FOLLOWING FINISHED FORMULATIONS ALONG WITH THEIR MANUFACTURING SITES AND INDIAN AUTHORIZED AGENTS FROM Dec 2007 TILL OCT, 2008

 

S.NO.

NAME OF DRUG

INDIAN AUTHORISED AGENT

NAME OF MANUFACTURER

DECEMBER 2007

LEUPROLIDE ACETATE 11.25MG

M/S. ABBOTT INDIA, MUMBAI

M/S. TAKEDA CHEMICAL

  1. LEFLUNOMIDE

  2. RILUZOLE

M/S. AVENTIS PHARMA, MUMBAI

M/S. AVENTIS INTERCONTINENTAL

DECEMBER 2007

LOPINAVIR/ROTINAVIR (ALUVIA) TAB

M/S. ABBOTT INDIA, MUMBAI

M/S. ABBOTT, GERMANY

JANUARY 2008

SORAFINIB 200MG TABLET

M/S. BAYER HEALTH, THANE

M/S. BAYER, GERMANY

ABRAXANE (NANOPARTICLE PACLITAXEL)

M/S. BIOCON LIMITED, BANGALORE

M/S. ABRAXIS BIOSCIENCE, USA

INJECTION LOW MOLECULAR WEIGHT HEPARIN

M/S. VHB LIFE SCIENCES, MUMBAI

M/S. HANGZHOU JIUYUAN, CHINA

  1. INJ. DACTINOMYCIN BP/USP

  2. INJ. PRALIDOXIME CHLORIDE

M/S. VHB LIFE SCIENCES, MUMBAI

M/S. KOREA UNITED PHARMA, KOREA

  1. STREPTOKINASE INJ

  2. UROKINASE INJ.

  3. HUMAN CHORIONIC

  4. INJ. HUMAN MENOPAUSAL

  5. HIGHLY PURIFIED FOLLICLE STIMULATING

M/S. VHB LIFE SCIENCES, MUMBAI

M/S. POLAMINE-WERK GMBH, GERMANY

DEFERASIROX (ASUNRA) DISP. TAB. 100MG & 400MG

M/S. NOVARTIS HEALTHCARE, MUMBAI

M/S. NOVARTIS PHARMA, SWITZERLAND

JANUARY 2008

GADOBENATE DIMEGLUMINE INJECTION

M/S. IMAGING PRODUCTS, MUMBAI

M/S. PATHEON ITALIA SPA, ITALY

FEBUARY 2008

GALVUS (VILDAGLIPTIN) TAB.

M/S. NOVARTIS, MUMBAI

M/S. NOVARTIS PHARMA, SWITZERLAND

FEBUARY 2008

SITAGLIPTIN PHOSPHATE

M/S. MSD PHARMA, BHIWANDI

M/S. MERCK & SHARP, ITALY

MARCH 2008

IRAESARYAN 300MG + HYDROCHLOROTHIAZDE 25MG TAB.


M/S. SANOFI SYNTHELABO MUMBAI.

M/S. SANOFI WIMTHROP, FRANCE

FLUDARABINE PHOSPHATE 10MG, ORAL TAB.

M/S. CADILA HEALTHCARE AHMEDABAD.

M/S. SCHERING AG, GERMANY.

VECORONIUM BROMIDE

M/S. CHANDRA BHAGAT MUMBAI.

M/S. HUONS CO. LTD, KOREA.

APRIL - 2008

SYSTANE LUBREICATING EYE DROPS.

M/S. ALCONLABS BANGALORE.

M/S. ALCON CUSI S.A. SPAIN.

17


  1. MICARDIS TAB. (TELMISARTAN 20 , 40,80, MG TAB.)

  2. MICARDIS PLUS TAB. ( TELMISARTAN + HYDROCHLO THIAZIDE)

M/S. BOEHRINGER INGELHEIM, MUMBAI.

M/S. BOEHRINGER INGELHEIM, GERMANY.

18

MIRAPEX TAB. ( PRAMIPEXOLE DI- HCL MONOHYDRATE)

M/S. M/S. BOEHRINGER INGELHEIM, MUMBAI.

M/S. BOEHRINGER INGELHEIM, GERMANY

19

HYALURONIC ACID INJECTION

M/S AJANTA PHARMA, MUMBAI

M/S PROLLENIUM MEDICAL TECH. INC. , CANADA

20

  1. TRANSPARENT ADHESIVE DRESSING WITH OR WITHOUT PAD.

  2. NON WOVEN ADHESIVE DRESSING WITH OR WITHOUT PAD.

M/S DERMACARE SURGICAL, MUMABI

M/S PHARMAPCAST S.A.E. EGYPT

21

EXELON PATCH

M/S NOVARTIS INDIA, MUMBAI

M/S LTS LOHMANNI, GERMANY

22

PURIFIED BOTULINUM TOXIN TYPE A COMPLEX

M/S RANBAXY LABS., NEW DELHI

M/S MEDY TOX INC., KOREA

23

MAY - 2008

  1. 5% GLUCOSE

  2. , 0.9% NACL

  3. 0.9% NACL 8.5% GLUCOSE

  4. 10% GLUCOSE

  5. COMPOUND SODIUM LACTACE

M/S B. BRAUN , MUMBAI

M/S B. BRAUN, GERMANY

24

PROSTAGLANDIN 500MG

M/S PAVOIUR PHARMA , MUMBAI

M/S PINT PHARMA, AUSTRIA

25

MILTAFOSINE CAPSULES

M/S CADILA HEALTHCARE, AHMEDABAD

M/S AMAREG, GERMANY

26

1.OLICLINOMEL (WITH ELECTROLYTE)

2. OLICLINOMEL (WITHOUT ELECTROLYTE)

M/S. BAXTER (I) PVT. LTD., GURGAON.

M/S. BAXTER BELGIUM.

27

JUNE - 2008


ELIDEL (PIMERCROLIMUS ) CREAM 1%

M/S NOVARTIS HEALTHCARE PVT. LTD., MUMBAI

M/S NOVARTIS PHARMA PRTODUCTIONS & GMBH, GERMANY

28

CYCLOSPORINE EYE DROPS 0.5MG /ML

M/S. ALLERGAN (I) BANGALORE.

M/S. ALLERGAN SALES U.S.A.

29

JULY - 2008


SKIN BARRIER MICROPOROUS SURGICAL TAPE LEUKOPOR

M/S BSN MEDICAL PVT. LTD., MUMBAI

M/S MODERN HEALTHCARE CORP., TAIWAN 520, CHINA

30

INJECTION LEUPROLIDE ACETATE DEPOT 3.75 & 11.25 MG (LECTRUM)

M/S MEDIGLOBE, NEW DELHI-60

M/S ERIOCHEM S.A., ARGRNTINA

31

PEMETREXED DISODIUM POWDER FOR SOLUTION

M/S. ELILILY & CO. HARAYANA.

M/S. LILY FRANCE S.A.S. FRANCE.

32

IMIPENEM+ CILASTATIN SODIUM USP INJ. 500MG

M/S M.S.D. PHARMACEUTICALN PVT. LTD., MAHARASHTRA-421302

M/S MERCK & CO., FRANCE

33

  1. SULPHER HEXAFLUORIDE POWDER & SOLVENT FOR INJ.


M/S. IMAGING PRODUCTS INDIA PVT. LTD., MUMBAI-400052

M/S. BRACCO IMAGING BV, SWITZERLAND

34

  1. IDARUBICIN HYDROCHLORIDE INJ. 5,10,20 MG (ZAVEDOS)

  2. DAUNORUBICIN HYDROCHLORIDE INJ. 20MG (DAUNOMYCIN)

  3. EPIRUBICIN HYDROCHLORIDE INJ. 10MG & 50MG (FARMORUBICIN RD)

  4. DOXORUBICIN HYDROCHLORIDE INJ. 10 MG & 50MG

M/S. PFIZER PRODUCTS INDIA PVT. LTD., MUMBAI-400102

M/S. PFIZER ITALIA S.R.L. ITALY

35

TELMISARTAN SD GRANULATES

M/S. BOEHRINGER INGELHEIM PVT., MUMBAI.

M/S. BOEHRINGER INGELHEIM GERMANY.

36

AUGUST – 2008


DAPTOMYCIN POWDER FOR


CONCENTRATE FOR SOLUTION FOR INFUSION

EACH VIAL CONTAINS:-

DEPTOMYCIN ….350mg/500mg

M/S. NOVARTIS HEALTH PVT. LTD., MUMBAI-400018

M/S. CATALENT PHARMA SOLUTIONS, USA

37

1. ACTICOAT STERILE DISPOSABLE DRESSING

M/S. SMITH & NEPHEW HEALTHCARE PVT. LTD., THANE

M/S. SMITH & NEPHEW MEDICAL LTD., UK having factory premises at M/S. NUCRYST PHARMACEUTICALS CORPORATIONS, CANADA

38

  1. TIGECYCLINE (LYOPHILISED POWDER FOR INJ. TYGACIL* 50MG) EACH VIAL CONTAINS:-

TIGECYCLINE………..50MG

M/S. WYETH LTD., MUMBAI-400018

M/S. WYETH PARENTERALS, PUERTO RICO-00987

39

1. FIXED DOSE COMBINATION OF SITAGLIPTIN PHOSPHATE AND METFORMIN HCI TABLETS (50mg/500mg & 1000mg

M/S. M.S.D. PHARMACEUTIC-ALS PVT. LTD., MAHARASHTRA-421302

M/S. FROSST S.A., SPAIN


SEPTEMBER - 2008



40

1.SODIUM HYALURONATE



M/S.COHERENT, MUMBAI

M/S.ANTEIS, SWITZERLAND.

41

1.POLIFEPROSAN 20 WITH CARMUSTIN IMPLANT.

M/S.RANBAXY LABORATERIES LTD. NEW DELHI-110019.

M/S.MGI PHARMA, USA.

42

PROACTIV SOLUTION REPAIRING LOTION

PROACTIV SOLUTION RENEWING CLEANSER

PROACTIV SOLUTION REFINING MASK

PROACTIV SOLUTION REVITALIZING TONER

M/S.GUTHY

MARKETING PVT. LTD. MUMBAI.

M/S.THIBIANT INTERNATIONAL , CHATSWORTH

43

PROACTIV SOLUTION REPAIRING LOTION

2. PROACTIV SOLUTION RENEWING CLEANSER

3. PROACTIV SOLUTION REFINING MASK

4. PROACTIV SOLUTION REVITALIZING TONER

M/S.GUTHY RENKER MARKTING PVT. LTD, MUMBAI.

M/S.COSMETICS LABORATORIES OF AMRICA.

44

1. OSELTAMIVIR CAPSULE FOR ORAL SUSP.

M/S.ROCHE SCIENTIFIC (INDIA).PVT, LTD, MUBAI-400018

M/S.G.HOFFMANN-LA ROCHE LTD, SWITZERLAND .

45

1. PEGAPTANIB SODIUM INJ.

M/S.PFIZER PRODUCTS PVT. LTD, MUMBAI-400102.

M/S.PFIZER IRELAND PHARMACEUTICALS. IRELAND .

46

DUROGESIC (D-TRANS FENTANYL.TRANSDERMAL PATCHES)-12MCH/HR

M/S.JOHNSON & JOHSON LTD. MUMBAI – 400036

M/S.JANSSEN PHARMACEUTICA N.V.BELGIUM

47

NITROGLYCERINDC INJ. 25MG/5ML

M/S.MEDIGLOBE, NEW DELHI -60

M/S. PH & T S.P. A., ITALY


OCTOBER - 2008



48

PROPLFOL 1% & 2% (MCT/CCT) INJ.

M/S.FRESENIUS KABI PUNE – 411001.

M/S.FRESENIUS KABI AUSTRIA GMBH, AUSTRIA.

49

HYAL PLUS INJ. (SODIUM HYALURONATE 1.5%)

M/S. L.G. LIFESCIENCES (I) PVT., LTD., NEW DELHI – 110029.

M/S. L.G.LIFE SCIENCES LTD., KOREA.

50

IXABEPILONE LYOPHILISED POWDER FOR INJECTION EACH VIAL CONTAINS IXBEPILONE-15MG/45MG.

M/S. BRISTOL MAYER SQUIBB MUMBAI.

M/S. BAXTER ONCOLOGY GMSH GERMANY.

51

ABATACEPT INJ-250MG.

M/S. BRISTOL MAYER SQUIBB MUMBAI.

M/S. BRISTOL MAYER SQUIBB PHARMA LTD., PUERTO RICO.

52

NICOTINE TRANSDESMAL SYSTEM (PATELES)36MG 78MG/114MG.

M/S. GLAXOSMITHKLINE GURGAON.

M/S. CATALENT UK PACHAJIJ LTD., U.K.

53

NICOTINE TRASDERMAL PATELETES 36/78/114MG

M/S. GLAXOSMITHKLINE GURGAON.


M/S. ALZA IRELAND LTD., IRELAND

54

VALSASTAN FILM COATED TAB 40MG/80MG/160MG/(DIOVAN)

M/S. NOVARTIS INDIA LTD., MUMBAI.

M/S. NOVARITS FARMACUETICA S.A. SPAIN

55

AMINOPLASMAL B.BRAUN 10%AMINOPLASMAL B.BRAUN 10%EAMINOPLASMAL B.BRAUN 5%E.

M/S. B. BRAUN MEDICAL (I) PVT., LTD., MUMBAI 400051

M/S. B.BRAUN NELSUNGEN AG, GERMANY.