Indian Companies Approved by International Regulatory Agencies

Indian Companies regularly used as source for Bulk Drugs and Formulations by developed countries

Name of Co. in India Approved By Exporting To Product
Calyx Chemicals & Pharma Ltd. US FDA/ European CoS USA/S. America/ Europe/ ME/ Asia Pyrazinamide & Zopiclone
Pearl Organics Ltd US FDA USA / Europe / Asia Metformin HCI
Chiron Behring Parent Company Asia / Egypt Rabipur Vaccine
Ranbaxy   USA / Europe Ranitidine (Generic)
Cefachlor (Generic)
Etodolac (Generic)
Cefadroxyl (Generic)
Acyclovir (Generic)
Amoxycillin (Generic)
Cephalexin (Generic)
Cheminor Drugs US FDA USA Ranitidine 75 mg (Generic)
Famotidine 20/40 mg (Generic)
Wockhardt US FDA USA Captopril tabs / Parentral infusions
SKB Parent Company Africa & ME Various tenders awarded to European business team
Glaxo UK MCA / TGA * UK Isogel / Fibrohealth
Sun Pharma US FDA USA / Europe Cephalosporin tabs
Lupin US FDA / UK MCA / MCC USA / UK / SA 7-ACCA, 7- ADCA, Cephalexin, Cefaclor, Oral Cephalosporin, Cephalosporin Injections, Rifampicin, Cefotaxime, Ceftrioxane vials
Dr. Reddy’s Lab US FDA USA / Europe Ciprofloxacin / Omeprazole Famotidine
Cipla US FDA / MCA / MCC / TGA USA / Europe / SA / Australia Ciprofloxacin / Roxithromycin/Bulk drugs /Formulations
IPCA Labs UK MHRA / MCC / TGA / US FDA UK / US / Europe / Australia Atenolol / Chloroquine Phosphate / Furosemide /  Hydroxychloroquine sulphate / Propranolol hydrochloride /  Pyrantel Pamoate / Pyrantel Tartrate / Trimethoprim
Shasun Chemicals US FDA / MCA / TGA / CoS (European Certificate of Suitability US / UK / Australia / European Union Ibuprofen / Ranitidine / Nizatidine
Strides Arcolab Ltd. U.S.A, Brazil, Mexico, MHRA, MCC, TGA/PIC, and ANVISA USA, Europe, UK, Australia, South Africa, Latin America, Russia, Africa and South East Soft Gelatin capsules, Tablets, Hard gelating capsules, Sachets, Liquid and dry powder steriles (including lypholisation), Beta lactams (solid orals tablets and capsules, and injectables)
Biocon India US FDA USA Lovastatin
Cadila Pharma TGA Australia Beta Lactam
Neuland Lab US FDA USA Albeturol Sulphate
Morepan Lab US FDA USA Loratidine
Unichem Laboratories Ltd MCA, MCC and TGA UK, SA and Ireland Amoxicillin, Bendrofluzide, Cetrizine, Formulations
J. B. Chemicals & Pharmaceuticals Ltd US FDA , TGA USA, Australia, Europe Metronidazole, Ciprofloxacin
Orchid Chemicals & Pharmaceuticals Ltd US FDA Europe Cephalexin
Krebs Biochemicals US FDA USA Pseudoephedrine I- Ephedrine
Matrix Laboratories Ltd   USA Citalopram
Divi's Laboratories Ltd EDQM Europe Naproxen / Nabumetone / Diltiazem HCl
Aurobindo Pharma Ltd UK MHRA/(UK MCA) Europe Citalopram
Alembic Limited EDQM Europe/US Roxithromycin
FDC Limited EDQM Europe Miconazole Nitrate
Kopran Ltd (KDL Biotech Ltd) MCC S. Africa Oral Powders/Sterile Ophtalmic  formulations
Zydus Cadila (Banyan Chemicals) US FDA USA Warfarin Sodium/ Defriprone/ Midodrin HCl
Glenmark Pharmaceuticals Ltd US FDA USA/America Amiodarone & Cilastazol
Micro Labs Ltd. UK MHRA US/UK/Europe Ranitidine, Erythromycin, Baclosen, Simvastatin
Vera Labs Ltd, a Div. of Matrix Labs Ltd US FDA USA Trazodone
Natco Pharma Ltd UK MHRA Europe Ondansetrong, Metronidazole
Accutest Research Laboratory US FDA USA Ciprofloxacin hydochloride
Global Calcium Pvt. Ltd. EDQM, European Cos. USA, Western Europe, South America, Australia, Japan, Middle East, Africa Gluconates, Orotates, Lactates, Citrates, Pyruvates, Malates, Lactbionates
Medreich Sterilab Ltd. UK-MHRA, TGA - Australia, South Africa - MCC, Health Canada UK, Europe, South America, Australia, Africa, Middle East and Far East. Betalactams, - Ciprofloxacin, Erythromycin, Cephalosporin Injections, Ranitidine, Omeprazole, Simvastatin, Atenolol, Amlodipine, Ibuprofen, Diclofenac, Metronidazole, Fluconazole, Metformin, Gliclazide, Chloroquine Sulphate, Trimethoprim, Norfloxacin.

* Awaiting approval WWMS (World Wide Marketing & Supplies) for plant at Nasik