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REGISTRATION CERTIFICATES ISSUED FOR THE

FOLLOWING FINISHED FORMULATIONS ALONGWITH

THEIR MANUFACTURING SITES AND INDIAN AUTHORIZED AGENTS

TILL DECEMBER, 2003

 

 

S. No.

NAMES OF DRUGS

 

MANUFACTURERS

AUTHORISED AGENTS IN INDIA

201.             

IVELIP 10% INTRAVENOUIS FAT EMULSION

M/s. CLINTEE PARENTAL, FRANCE

M/s. BAXTER (INDIA) PVT. LTD., GURGAON

202.             

IVELIP 20% INTRAVENOUS FAT EMULSION

M/s. CLINTEE PARENTAL, FRANCE

M/s. BAXTER (INDIA) PVT. LTD., GURGAON

203.             

CLINOMEL N4-550, PARENTERAL NUTRITION SOLUTION

M/s. CLINTEE PARENTAL, FRANCE

M/s. BAXTER (INDIA) PVT. LTD., GURGAON

204.             

CLINOMEL N5-800, PARENTERAL NUTRITION SOLUTION

M/s. CLINTEE PARENTAL, FRANCE

M/s. BAXTER (INDIA) PVT. LTD., GURGAON

205.             

CLINOMEL N6-900, PARENTERAL NUTRITION SOLUTION

M/s. CLINTEE PARENTAL, FRANCE

M/s. BAXTER (INDIA) PVT. LTD., GURGAON

206.             

CLINOMEL N-1000, PARENTERAL NUTRITION SOLUTION

M/s. CLINTEE PARENTAL, FRANCE

M/s. BAXTER (INDIA) PVT. LTD., GURGAON

207.             

PLASMA LYTE A INJECTION IN Ph 704, MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP

M/s. BAXTER HEALTHCARE CORPORATION, USA

M/s. BAXTER (INDIA) PVT. LTD., GURGAON

208.             

0.9% SODIUM CHLORIDE INJECTION USP

M/s. BAXTER HEALTHCARE CORPORATION, USA

M/s. BAXTER (INDIA) PVT. LTD., GURGAON

209.             

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP FORMULA (ACD-A)

M/s. BAXTER HEALTHCARE CORPORATION, USA

M/s. BAXTER (INDIA) PVT. LTD., GURGAON

210.             

TOPIRAMATE TABLETS 25mg, 50mg & 100mg

M/s. CILAG AG, SWITZERLAND

M/s. JOHNSON & JOHNSON LIMITED, MUMBAI

211.             

FLUNIXIN MEGLUMINE 50mg/ml INJECTION (FLUNIXIN)

M/s. NORBOOK LABORATORIES LIMITED, IRELAND

M/s. HELPRO HEALTH PRODUCTS & SERVICES, INDORE

212.             

GANIRELIX SOLUTION FOR INJECTION 0.25mg/0.5Ml (ORGALUTRAN)

M/s. ORGANON (IRELAND) LIMITED, IRELAND

M/s. ORGANON (INDIA) LTD., KOLKATA

213.             

FOLLITROPIN BETA FSH INJECTION 300IU, 600IU (RECAGON)

M/s. ORGANON (IRELAND) LIMITED, IRELAND

M/s. HELPRO HEALTH PRODUCTS & SERVICES, INDORE

214.             

COMBINATION OF FOLLICLE STIMULATING HORMONE AND LUTENISING HORMONE 75IU (PERGONAL)

M/s. LABORATORIES SERONO S.A., SWITZERLAND

M/s. SERUM INTERNATIONAL LIMITED, PUNE

215.             

CHORIONIC GONADOTROPHIN AMPOULES 2000/5000/10000IU (PROFASI)

M/s. LABORATORIES SERONO S.A., SWITZERLAND

M/s. SERUM INTERNATIONAL LIMITED, PUNE

216.             

UROFOLLITROPHIN-FOLLICLE STIMULATING HORMONE 75IU (METRODIN)

M/s. LABORATORIES SERONO S.A., SWITZERLAND

M/s. SERUM INTERNATIONAL LIMITED, PUNE

217.             

r-DNA HUMAN GROWTH HORMONE 4IU & 10IU [SAIZEN (SOMATROPIN)]

M/s. LABORATORIES SERONO S.A., SWITZERLAND

M/s. SERUM INTERNATIONAL LIMITED, PUNE

218.             

r-DNA FOLLICLE STIMULATING HORMONE-FOLLITROPIN ALFA 75IU & 150IU (GONAL-F)

M/s. LABORATORIES SERONO S.A., SWITZERLAND

M/s. SERUM INTERNATIONAL LIMITED, PUNE

219.             

AMIODARONE HYDROCHLORIDE INJECTION 150mg/3ml (CORDARONE INJECTION)

M/s. SANOFI WINTHROP INDUSTRIE, FRANCE

M/s. SANOFI-SYTHELABO (INDIA) LTD., MUMBAI

220.             

MILRINONE LACTATE INJECTION 10mg/10ml (PRIMACOR INJECTION)

M/s. SANOFI WINTHROP INDUSTRIE, FRANCE

M/s. SANOFI-SYTHELABO (INDIA) LTD., MUMBAI

221.             

NADROPARIN CALCIUM INJECTION—FRAXIPARINE INJECTION (Prefilled syringes): 0.2ml, 0.3ml, 0.4ml, 0.6ml, 0.8ml, 1.0ml (9500 IU Axa/ml), FRAXODI (Prefilled syringes): 0.6ml, 0.8ml, 1.0ml (19000 IU Axa/ml, FRAXIPARINE MULTIDOSE (vials):5ml, 15ml (9500IU Axa/ml)

M/s. SANOFI WINTHROP INDUSTRIE, FRANCE

M/s. SANOFI-SYTHELABO (INDIA) LTD., MUMBAI

222.             

ADENOSONE INJECTION 6mg/2ml (ADENOCOR INJECTION)

M/s. SANOFI WINTHROP INDUSTRIE, FRANCE

M/s. SANOFI-SYTHELABO (INDIA) LTD., MUMBAI

223.             

MILTEFOSINE CAPSULES 10mg AND 50mg (IMPAVIDO)

M/s. INSTITUT DE DEVELOPMENT, FRANCE

M/s. GERMAN REMEDIES LIMITED, MUMBAI

229.             

HYALOVET INJECTION 20mg/2ml PRE-FILLED SYRINGES (HYALURONIC ACID as sodium salt for intra-articular injection in veterinary use)

M/s. FIDIA FARMACEUTICIS S.p.A., ITALY

M/s. HELPRO HEALTH PRODUCTS & SERVICES, INDORE

230.             

HUMAN CHORIONIC GONADOTROPHIN INJECTION (PREGNYL 1500IU/5000IU)

M/s NV ORGANON, THE NETHERLANDS

M/s ORGANON (INDIA) LIMITED, KOLKATA

231.             

TIBOLONE 2.5mg TABLETS (LIVIAL)

M/s NV ORGANON, THE NETHERLANDS

M/s ORGANON (INDIA) LIMITED, KOLKATA

232.             

DESOGESTREL 0.075mg TABLETS (CERAZETTE)

M/s NV ORGANON, THE NETHERLANDS

M/s ORGANON (INDIA) LIMITED, KOLKATA

233.             

DESOGESTREL 0.15 + ETHINYLESTRADIOL 0.03mg TABLETS (MERVELON)

M/s NV ORGANON, THE NETHERLANDS

M/s ORGANON (INDIA) LIMITED, KOLKATA

234.             

DESOGESTREL 0.15 + ETHINYLESTRADIOL 0.02mg TABLETS (MERCILON)

M/s NV ORGANON, THE NETHERLANDS

M/s ORGANON (INDIA) LIMITED, KOLKATA

235.             

FOLLITROPIN BETA (FSH) LYOSPHERE / SOLUTION FOR INJECTION (RECAGON 500IU/100IU/150IU)

M/s NV ORGANON, THE NETHERLANDS

M/s ORGANON (INDIA) LIMITED, KOLKATA

236.             

PANCURONIUM BROMIDE INJECTION (PAVULON 4mg=2ml)

M/s NV ORGANON, THE NETHERLANDS

M/s ORGANON (INDIA) LIMITED, KOLKATA

237.             

VECURONIUM BROMIDE INJECTION (NORCURON 4mg/10mg)

 

M/s NV ORGANON, THE NETHERLANDS

M/s ORGANON (INDIA) LIMITED, KOLKATA

238.             

ROCURONIUM BROMIDE INJECTION (ESMERON 50mg=5ml, 100mg=10ml, 250mg=25ml)

M/s NV ORGANON, THE NETHERLANDS

M/s ORGANON (INDIA) LIMITED, KOLKATA

239.             

BCG STRAIN TICE 2-8 x 10 CFU per ampoule / vial, powder for instillation fluid for intravesical use (Onco TICE)

M/s NV ORGANON, THE NETHERLANDS

M/s ORGANON (INDIA) LIMITED, KOLKATA

240.             

PYROXICAM- BETA-CYCLODEXTRIN TABLET (CYCLADOL) –Each tablet containing 191.2mg of pyroxicam-beta-cyclodextrin, equivalent to 20mg of pyroxicam

M/s NV ORGANON, THE NETHERLANDS

M/s ORGANON (INDIA) LIMITED, KOLKATA

241.             

DUROGESIC (FENTANYL TRANSDERMAL THERAPEUTIC PATCHES) TTS 25mcg/hr

 

DUROGESIC (FENTANYL TRANSDERMAL THERAPEUTIC PATCHES) TTS 50mcg/hr

 

DUROGESIC (FENTANYL TRANSDERMAL THERAPEUTIC PATCHES) TTS 75mcg/hr

 

DUROGESIC (FENTANYL TRANSDERMAL THERAPEUTIC PATCHES) TTS 100mcg/hr

M/s. JANSSEN PHARMACEUTICA NV., BELGIUM

M/s. JOHNSON & JOHNSON LIMITED, MUMBAI

242.             

DIANEAL PD-2 PERITONEAL DIALYSIS SOLUTION WITH 1.5% DEXTROSE

M/s. BAXTER HEALTHCARE PTE LTD., SINGAPORE

M/s. BAXTER (INDIA) PVT. LTD., GURAGAON, HARYANA

243.             

DIANEAL PD-2 PERITONEAL DIALYSIS SOLUTION WITH 2.5% DEXTROSE

M/s. BAXTER HEALTHCARE PTE LTD., SINGAPORE

M/s. BAXTER (INDIA) PVT. LTD., GURAGAON, HARYANA

244.             

DIANEAL PD-2 PERITONEAL DIALYSIS SOLUTION WITH 4.25% DEXTROSE

M/s. BAXTER HEALTHCARE PTE LTD., SINGAPORE

M/s. BAXTER (INDIA) PVT. LTD., GURAGAON, HARYANA

245.             

DIANEAL PD-2 PERITONEAL DIALYSIS SOLUTION, ULTRABAG, WITH 1.5% DEXTROSE

M/s. BAXTER HEALTHCARE PTE LTD., SINGAPORE

M/s. BAXTER (INDIA) PVT. LTD., GURAGAON, HARYANA

246.             

DIANEAL PD-2 PERITONEAL DIALYSIS SOLUTION, ULTRABAG, WITH 2.5% DEXTROSE

M/s. BAXTER HEALTHCARE PTE LTD., SINGAPORE

M/s. BAXTER (INDIA) PVT. LTD., GURAGAON, HARYANA

247.             

DIANEAL PD-2 PERITONEAL DIALYSIS SOLUTION, ULTRABAG, WITH 4.25% DEXTROSE

M/s. BAXTER HEALTHCARE PTE LTD., SINGAPORE

M/s. BAXTER (INDIA) PVT. LTD., GURAGAON, HARYANA

248.             

LOW CALCIUM PERITONEAL DIALYSIS SOLUTION WITH 1.5 % DEXTROXE

M/s. BAXTER HEALTHCARE PTE LTD., SINGAPORE

M/s. BAXTER (INDIA) PVT. LTD., GURAGAON, HARYANA

249.             

LOW CALCIUM PERITONEAL DIALYSIS SOLUTION WITH 2.5 % DEXTROXE

 

M/s. BAXTER HEALTHCARE PTE LTD., SINGAPORE

M/s. BAXTER (INDIA) PVT. LTD., GURAGAON, HARYANA

250.             

LOW CALCIUM PERITONEAL DIALYSIS SOLUTION WITH 4.25 % DEXTROXE

M/s. BAXTER HEALTHCARE PTE LTD., SINGAPORE

M/s. BAXTER (INDIA) PVT. LTD., GURAGAON, HARYANA

251.             

LOW CALCIUM PERITONEAL DIALYSIS SOLUTION, ULTRABAGS WITH 1.5 % DEXTROXE

M/s. BAXTER HEALTHCARE PTE LTD., SINGAPORE

M/s. BAXTER (INDIA) PVT. LTD., GURAGAON, HARYANA

252.             

LOW CALCIUM PERITONEAL DIALYSIS SOLUTION, ULTRABAGS WITH 2.5 % DEXTROXE

M/s. BAXTER HEALTHCARE PTE LTD., SINGAPORE

M/s. BAXTER (INDIA) PVT. LTD., GURAGAON, HARYANA

253.             

LOW CALCIUM PERITONEAL DIALYSIS SOLUTION, ULTRABAG WITH 4.25 % DEXTROXE

M/s. BAXTER HEALTHCARE PTE LTD., SINGAPORE

M/s. BAXTER (INDIA) PVT. LTD., GURAGAON, HARYANA

254.             

METOPROLOL SUCCINATE CONTROLLED RELEASE TABLETS 25mg, 50mg, 100mg & 200mg (SELOKEN-XL)

M/s. ASTRAZENECA AB, SWEDEN

M/s. ASTRAZENECA PHARMA INDIA LIMITED, BANGALORE

255.             

SOLU-MEDROL STERILE POWDER 500mg & 1g

M/s. PHARMACIA & UPJOHN COMPANY, USA

M/s. PHARMACIA INDIA PRIVATE LIMITED, GURGAON

256.             

ATGAM STERILE SOLUTION 50mg/ml

M/s. PHARMACIA & UPJOHN COMPANY, USA

M/s. PHARMACIA INDIA PRIVATE LIMITED, GURGAON

257.             

 DALACIN T TOPICAL GEL 1%

M/s. PHARMACIA & UPJOHN COMPANY, USA

M/s. PHARMACIA INDIA PRIVATE LIMITED, GURGAON

258.             

HUMAN CHORIONIC GONADOTROPHIN INJECTION (HCG)

M/s. SHANGHAI NO. 1 BIOCHEMICAL AND PHARMACEUTICAL CO. LTD., CHINA

M/s. LIFE MEDICARE & BIOTECH PVT. LTD., NEW DELHI

259.             

HUMAN MENOPAUSAL GONADOTROPHIN INJECTION (HMG)

M/s. SHANGHAI NO. 1 BIOCHEMICAL AND PHARMACEUTICAL CO. LTD., CHINA

M/s. LIFE MEDICARE & BIOTECH PVT. LTD., NEW DELHI

260.             

UROKINASE INJECTION (MEDINASE)

M/s. SHANGHAI NO. 1 BIOCHEMICAL AND PHARMACEUTICAL CO. LTD., CHINA

M/s. LIFE MEDICARE & BIOTECH PVT. LTD., NEW DELHI

261.             

HUMAN FOLLICLE STIMULATING HORMONE (FSH)

M/s. SHANGHAI NO. 1 BIOCHEMICAL AND PHARMACEUTICAL CO. LTD., CHINA

M/s. LIFE MEDICARE & BIOTECH PVT. LTD., NEW DELHI

262.             

PYROXICOM-BETA CYCLODAXIM

M/s. CHIESI FARMACEUTIEI SPA., ITALY

M/s. RANBAXY LABS. LTD.,NEW DELHI

263.             

VINORELBINE INJECTION 10mg & 50mg

M/s. ERIOCHEM S.A., ARGENTINA

M/s. ESSCHEM PVT. LTD., MUMBAI

264.             

AMPHOTERICIN BINLIPID COMPLEX

M/s. ELAN PHARMA LTD., USA

M/s. ALPHA DRUGS, NEW DELHI

265.             

RECOMBINANT HUMAN ERYTHROPOIETIN INJECTIONS 1000IU / 2000IU / 3000IU / 4000IU & 10000IU0

 

 

M/s. BIO SIDUS SA., ARGENTINA

M/s. CADILA HEALTHCARE LTD., AHMEDABAD

266.             

RECOMBINANT HUMAN INTERFERON ALPHA-2b INJECTIONS  3MIU / 5MIU & 10MIU

M/s. BIO SIDUS SA., ARGENTINA

M/s. CADILA HEALTHCARE LTD., AHMEDABAD

267.             

BOTOLLIUM TOXIN TYPE A INJECTION

M/s ALLERGAN PHARMACEUTICAL, IRELAND

M/s. HxH PHARMACEUTICALS PVT. LTD., MUMBAI

268.             

CARBOXY METHYL CELLULOSE LUBRICANT EYE DROPS 1%

M/s. ALLERGAN PHARMACEUTICALS, IRELAND

M/s. ALLERGAN (INDIA) LTD., BANGALORE

269.             

IORT MONOCLONAL ANTIBODY

M/s. CENTRE OF MOLECULAR IMMUNOLOGY, CUBA

M/s. USV LIMITED, MUMBAI

270.             

MESALAZINE 500mg TABS.

M/s. FERRING A/S, DENMARK

M/s. FERRING PHARMACEUTICALS PVT. LTD., MUMBAI

271.             

PROLONGED RELEASE TABLETS

M/s. FERRING A/S, DENMARK

M/s. FERRING PHARMACEUTICALS PVT. LTD., MUMBAI

272.             

TRIPTORELIM ACETILE INJECTION 3.7mg & 0.1mg

M/s. FERRING GMBH, GERMANY

M/s. FERRING PHARMACEUTICALS PVT. LTD., MUMBAI

273.             

CHORIONIC GONADOTROPHIN INJECTION 5000 IU

M/s. FERRING GMBH, GERMANY

M/s. FERRING PHARMACEUTICALS PVT. LTD., MUMBAI

274.             

MENOTROPHIN INJECTION 75 I.U.

 

 

M/s. FERRING GMBH, GERMANY

M/s. FERRING PHARMACEUTICALS PVT. LTD., MUMBAI

275.             

SOMATOSTATIN INJECTION 3mg

M/s. FERRING GMBH, GERMANY

M/s. FERRING PHARMACEUTICALS PVT. LTD., MUMBAI

276.             

TERLIPRESSIN INJECTION 1.0mg

M/s. FERRING-LECIVA, CZECH REPUBLIC

M/s. FERRING PHARMACEUTICALS PVT. LTD., MUMBAI

277.             

CAELYX (LIPOSOMAL DOXORUBIN 20mg / 50mg)

 

M/s. BENVENUE LABS INC., USA

M/s. FULFORD (INDIA) LIMITED, MUMBAI

278.             

SURGICAL SUTURES USP

M/s. JOHNSON & JOHNSON INTERNATIONAL, BELGIUM

M/s. JOHNSON & JOHNSON LIMITED, MUMBAI

279.             

CARBOXY METHYL CELLULOSE SODIUM LUBRICANT EYE DROP 1% (15ml-30ml-refresh liquigel)

M/s. ALLERGANS SALES LLC., USA

M/s. ALLERGAN INC., BANGALORE

280.             

BIMATOPROST OPTHALMIC SOLUTION 0.03% (LUMIGAN)

M/s. ALLERGANS SALES LLC., USA

M/s. ALLERGAN INC., BANGALORE

281.             

STREPTOKINASE INJECTION 150000 IU, 1500000IU

M/s. AVENTIS BEHRING GMBH, GERMANY

M/s. CRITIPHARMA, MUMBAI

282.             

SURGICAL SUTURES USP

M/s. ETHICAN INC., USA

M/s. JOHNSON & JOHNSON LIMITED

283.             

ISOFLURANE USP (AERRANE) 100ml & 250ml glass bottles-Inhalation anesthetic.

 

M/s. BAXTER HEALTHCARE CORP., USA

M/s. BAXTER INDIA PVT. LTD., GURGOAN

284.             

DERMOBAND TOPICAL SKIN ADHESINE

 

M/s. CLOSURE MEDICAL CORPORATION, USA

M/s. JOHNSON & JOHNSON LIMITED

285.             

HCG INJECTION

M/s. INSTITUTO MASSENE SRL., ARGENTINA

M/s. CHEMECH LABS LTD., CHENNAI

286.             

FSH + LH INJECTION                 

M/s. INSTITUTO MASSENE SRL., ARGENTINA

M/s. CHEMECH LABS LTD., CHENNAI

287.             

FSH INJECTION

M/s. INSTITUTO MASSENE SRL., ARGENTINA

M/s. CHEMECH LABS LTD., CHENNAI

288.             

SODIUM HYULURONATE 1% INJECTION

M/s. BIO TECHNOLOGY GENERAL, ISAREAL

M/s. NIRANS (I) PVT. LTD., MUMBAI

289.             

ONE ALFHA CAPS.

M/s. LEO PHARMACEUTICALS BALLERUP, DENMARK

M/s. RANABXY LABS. LTD., NEW DELHI

290.             

DAIVONEX SCALP SOLUTION

M/s. LEO PHARMACEUTICALS BALLERUP, DENMARK

M/s. RANABXY LABS. LTD., NEW DELHI

291.             

INNOHIP INJECTION

M/s. LEO PHARMACEUTICALS BALLERUP, DENMARK

M/s. RANABXY LABS. LTD., NEW DELHI

292.             

PORCINE INSULIN-CHROMATOGRAPHICALLY PURIFIED

M/s. TARCHOMINSHKIE DOLFA, POLAND

M/s. CADILA PHARMACEUTICALS LTD., AHEMDABAD

293.             

HIGHLY PURIFIED PORCINE INSULIN

M/s. TARCHOMINSHKIE DOLFA, POLAND

M/s. CADILA PHARMACEUTICALS LTD., AHEMDABAD

294.             

HCG INJECTION 1000, 2000, 5000 & 10000 IU

M/s. IBSA INSTITUE SA., SWITZERLAND

M/s. WIN MEDICINES LTD., NEW DELHI

295.             

HMG INJECTION 75IU / 150 IU

M/s. IBSA INSTITUE SA., SWITZERLAND

M/s. WIN MEDICINES LTD., NEW DELHI

296.             

FSH INJECTION 75IU / 150IU

M/s. IBSA INSTITUE SA., SWITZERLAND

M/s. WIN MEDICINES LTD., NEW DELHI

297.             

BETAMETHASONE TAB. 0.5mg

M/s. PT SCHERING PLOUGH, INDONESIA

M/s FULFORD

 (I) LIMITED, MUMBAI

298.             

DEXCHLORPHCNIRAMINE
TAB. 2mg

M/s. PT SCHERING PLOUGH, INDONESIA

M/s FULFORD (I) LIMITED, MUMBAI

 

299.             

LANTUS INSULIN (GLARCINE)

M/s. AVENTIS PHARMA GMBH, GERMANY

M/s. AVENTIS PHARMA LTD., MUMBAI

300.             

HUMAN INSULIN (INSUMAN)

M/s. AVENTIS PHARMA GMBH, GERMANY

M/s. AVENTIS PHARMA LTD., MUMBAI


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