List of APIs
| API | Grade | CAS No. | Documentation | Regulatory Approvals |
| Anti-Histamine / Anti-Cholinergic | ||||
| Buclizine HCl | BP | 129-74-8 | eCTD DMF, ASMF | 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,NMPA(China), MOH(Russia), MOH-Taiwan |
| Cyproheptadine HCl | EP,BP,USP, IP | 41354-29-4 | eCTD DMF | COFEPRIS, WHO GMP,NMPA(China), EU- WC, MOH-Taiwan, |
| Meclizine HCl | EP, BP, USP | 31884-77-2 | eCTD DMF, JDMF, CEP,CADIFA | EDQM, PMDA Japan, WHO GMP, EU-WC, COFEPRIS, MEB-Netherland, MOH-Taiwan, ANVISA |
| Flunarizine HCl | EP, BP | 30484-77-6 | eCTD DMF, CEP | EDQM, COFEPRIS, WHO GMP, EU-WC, MOH-Taiwan, ANVISA, NMPA(China), CADIFA (U/R) |
| Hydroxyzine HCl | USP, EP, IP | 2192-20-3 | Ectd DMF, CEP, US DMF(U/R),KDMF | WHO GMP, EU-WC, Korea(U/R) |
| 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) |
| Etofenamate | EP | 30544-47-9 | Tech Pack | NONE |
| Pentoxifylline | EP, USP | 6493-05-6 | eCTD DMF | WHO GMP, EU-WC, NMPA(China) |
| 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,USP(Draft) | 155206-00-1 | eCTD DMF | WHO-GMP, EU-WC, Health Canada(U/R) |
| Travoprost | USP | 157283-68-6 | Tech Pack | NONE |
| Misoprostol Dispersion | USP | 59122-46-2 | eCTD DMF | GMP, WHO GMP |
| Cardiovascular | ||||
| Diltiazem HCl | EP, USP, IP | 33286-22-5 | eCTD DMF, CEP | WHO GMP,EU- WC, KFDA (U/R), NMPA(China) |
| Anesthetic | ||||
| Prilocaine | EP | 721-50-6 | eCTD DMF | GMP |
| Propofol | USP, EP | 2078-54-8 | Tech pack | None |
| Epilepsy | ||||
| Topiaramte | USP,EP | 97240-79-4 | eCTD DMF | WHO-GMP(U/R),EU-WC(U/R) |
| API | Grade | CAS No. | Documentation | Regulatory Approvals |
| Anti-Histamine / Anti-Cholinergic | ||||
| Ketotifen Fumarate | EP,IP,USP | 34580-14-8 | eCTD DMF, ASMF(Bulgaria),KDMF | WHO GMP, EU-WC,KFDA |
| Wilson’s Disease | ||||
| D-Penicillamine | IP,USP, EP | 52-67-5 | eCTD DMF, CEP, ASMF | WHO-GMP,EU-WC,NMPA(China)(U/R),US FDA |
| Treat Osteoporosis | ||||
| Ibandronate Sodium Monohydrate | IH, EP,USP | 138926-19-9 | eCTD DMF,KDMF, CEP | KFDA, WHO GMP, EU- WC,NMPA(China)(U/R),ANVISA(U/R),CADIFA(U/R) |
| Risedronate Sodium (HH/AH) | EP, USP, IP, IH | 115436-72-1 | eCTD DMF,KDMF, CEP | KFDA,WHO GMP, EU- WC, ANVISA(U/R),CADIFA(U/R) |
| Anti-Muscarinic | ||||
| Tolterodine Tartrate | USP, IH, EP | 124937-52-6 | eCTD DMF, CEP | WHO-GMP, EU-WC |
| Trospium Chloride | EP,USP,IP | 10405-02-4 | eCTD DMF | GMP,CEP(U/R) |
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”
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