List of APIs
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Unit I
API | Grade | CAS No. | Documentation | Regulatory Approvals |
Anti-Histamine / Anti-Cholinergic | ||||
Buclizine HCl | BP | 129-74-8 | eCTD DMF | COFEPRIS, WHO GMP, MHRA,HPRA, EU-WC, Portugal,Israel, Malta, MOH-Taiwan |
Cinnarizine | EP, BP, IP | 298-57-7 | eCTD DMF, CEP | EU-GMP, COFEPRIS, WHO GMP,EU-WC, IDL(China), MOH(Russia), MOH-Taiwan |
Cyclizine HCl | EP, BP, USP | 82-92-8 | eCTD DMF | WHO GMP, EU-WC, South Africa |
Cyproheptadine HCl | EP,BP,USP, IP | 41354-29-4 | eCTD DMF | COFEPRIS, WHO GMP,IDL(China), EU- WC, MOH-Taiwan, |
Meclizine HCl | EP, BP, USP | 31884-77-2 | eCTD DMF, JDMF, CEP | EDQM, PMDA Japan, WHO GMP, EU-WC, COFEPRIS, MEB-Netherland, MOH-Taiwan, ANVISA,CADIFA (U/R) |
Flunarizine HCl | EP, BP | 30484-77-6 | eCTD DMF, CEP | EDQM, COFEPRIS, WHO GMP, EU-WC, MOH-Taiwan, ANVISA |
Hydroxyzine HCl | USP, EP, IP | 2192-20-3 | Ectd DMF, CEP(U/R), US DMF (U/R) | WHO GMP, EU-WC |
Hydroxyzine Pamoate | USP | 68-88-2 | Techpack | |
Muscle relaxant / Pain Management | ||||
Carisoprodol | EP, USP, IP | 78-44-4 | eCTD DMF | ANVISA, COFEPRIS, WHO GMP, EU-WC, MOH (Taiwan) |
Etodolac | EP, USP, IP | 41340-25-4 | eCTD DMF, CEP | EDQM, WHO-GMP, EU-WC, ANVISA,CADIFA (U/R) |
Pentoxifylline | EP, USP | 06-05-6493 | eCTD DMF | WHO GMP, EU-WC, IDL (China) (U/R) |
Cilostazol | USP | 73963-72-1 | DMF | GMP. |
Anti-Diarrheal | ||||
Loperamide HCl | EP, BP, USP | 34552-83-5 | eCTD DMF, CEP | WHO GMP, COFEPRIS, MOH(Russia), EU-WC, EDQM, MOH-Taiwan |
Prostaglandins | ||||
Bimatoprost | IH | 155206-00-1 | eCTD DMF | WHO-GMP, EU-WC |
Misoprostol | USP | 59122-46-2 | Tech Pack | GMP |
Cardiovascular | ||||
Diltiazem HCl | EP, USP, IP | 33286-22-5 | eCTD DMF, CEP | WHO GMP,EU- WC, KFDA (U/R) |
Anesthetic | ||||
Prilocaine | EP | 721-50-6 | Tech pack | None |
Propofol | USP, EP | 2078-54-8 | Tech pack | None |
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Unit II
API | Grade | CAS No. | Documentation | Regulatory Approvals |
Anti-Histamine / Anti-Cholinergic | ||||
Ketotifen Fumarate | EP, IP | 34580-14-8 | eCTD DMF, ASMF (U/R) | WHO GMP, EU-WC |
Wilson’s Disease | ||||
D-Penicillamine | IP,USP, EP | 52-67-5 | eCTD DMF, CEP (U/R), ASMF (France) | WHO-GMP, EU-WC |
Treat Osteoporosis | ||||
Ibandronate Sodium Monohydrate | IH, EP | 138926-19-9 | eCTD, DMF KDMF, CEP (U/R) | KFDA, WHO GMP, EU- WC |
Risedronate Sodium (HH/AH) | EP, USP, IP, IH | 115436-72-1 | eCTD DMF KDMF, CEP | KFDA WHO GMP, EU- WC, ANVISA |
Anti-Muscarinic | ||||
Tolterodine Tartrate | USP, IH, EP | 124937-52-6 | eCTD DMF, CEP (U/R), | WHO-GMP, EU-WC |
Trospium Chloride | EP | 10405-02-4 | Tech Pack | GMP |
Note:
- Products covered under Patent will not be supplied to the countries where Patents are valid
- Products covered under valid Patent are available for R & D use only
- U/R – “Under Review”, IH – “In-house”