API |
Manufacturing Unit |
Grade |
CAS No. |
Documentation |
Regulatory Approvals |
Anti-Histamine / Anti-Cholinergic |
Buclizine HCl |
Unit – I |
BP, IP |
129-74-8 |
CTD DMF |
COFEPRIS, WHO GMP, WC, IRELAND |
Cinnarizine |
Unit – I |
EP, BP, IP |
298-57-7 |
CTD DMF, EDMF, CEP |
COFEPRIS, WHO GMP, WC, IDL(China), MOH(Russia),EUGMP |
Cyclizine HCl |
Unit – I |
EP, BP, USP |
82-92-8 |
CTD DMF |
WHO GMP |
Cyproheptadine HCl |
Unit – I |
EP, BP, USP |
41354-29-4 |
CTD DMF |
COFEPRIS, WHO GMP, IDL(China) |
Meclizine HCl |
Unit – I |
EP, BP, USP |
31884-77-2 |
CTD DMF, CEP(U/R), JDMF, USDMF |
PMDA Japan, WHO GMP, WC, COFEPRIS, Netherlands |
Oxatomide IH |
Unit – I |
IH |
60607-34-3 |
CTD DMF |
WHO GMP |
Hydroxyzine HCl |
Unit – I |
USP, EP |
2192-20-3 |
DMF: SEP-18 |
GMP |
Ketotifen Fumarate |
Unit – II |
EP, BP |
34580-14-8 |
CTD DMF |
WHO GMP |
Muscle relaxant / Pain Management |
Carisoprodol |
Unit – I |
EP, USP, IP |
78-44-4 |
CTD DMF, USDMF |
COFEPRIS, WHO GMP |
Etodolac |
Unit – I |
EP, BP, USP, IP |
41340-25-4 |
CTD DMF, CEP, USDMF |
WHO GMP |
Pentoxifylline |
Unit – I |
EP, USP |
06-05-6493 |
CTD DMF, CEP(U/R) |
WHO GMP |
Cardiovascular |
Diltiazem HCl |
Unit – I |
EP, BP, USP, IP |
33286-22-5 |
CTD DMF : Aug-18, USDMF, CEP : Nov-18 |
WHO GMP |
Clopidogrel Form II |
Unit – I |
EP, USP, IP |
120202-66-6 |
CTD DMF : May-18, USDMF, CEP : Jun-18 |
GMP |
Anti-Migraine |
Flunarizine HCl |
Unit – I |
EP, BP |
30484-77-6 |
CTD DMF, EDMF,CEP(U/R) |
COFEPRIS, WHO GMP, WC |
Chelating agent |
Etidronate Disodium |
Unit – I |
EP, USP |
7414-83-7 |
CTD DMF |
CANADIAN AUTHORITY |
Anti-Diarrheal |
Loperamide HCl |
Unit – I |
EP, BP, USP |
34552-83-5 |
CTD DMF, EDMF, CEP (U/R) |
WHO GMP, COFEPRIS, MOH(Russia) |
Glaucoma, Ocular Hypertension |
Latanoprost |
Unit – I |
IH |
130209-82-4 |
DMF : Sep-18 |
GMP |
Bimatoprost |
Unit – I |
IH |
155206-00-1 |
DMF : Sep-18 |
GMP |
Travoprost |
Unit – I |
IH |
157283-68-6 |
DMF : Sep-18 |
GMP |
Ocular Hypertension |
Tafluprost |
Unit – I |
IH |
209860-87-7 |
DMF : Sep-18 |
GMP |
Oxytocic |
Carboprost |
Unit – I |
IH |
58551-69-2 |
DMF : Sep-18 |
GMP |
Misoprostol |
Unit – I |
IH |
59122-46-2 |
DMF : Sep-18 |
GMP |
Treat Wilson’s Disease |
D-Penicillamine |
Unit – II |
IP, EP, USP |
52-67-5 |
TechPack |
GMP |
Treat Osteoporosis |
Ibandronate Sodium |
Unit – II |
IH |
138926-19-9 |
CTD DMF, KDMF |
KFDA, WHO GMP |
Risedronate Sodium (HH/AH) |
Unit – II |
EP, BP, USP |
115436-72-1 |
CTD DMF, KDMF |
KFDA, WHO GMP |
Anti-Muscarinic |
Tolterodine Tartrate |
Unit – II |
IP, USP, IH |
124937-52-6 |
CTD DMF |
WHO GMP |