APPROVALS & DMFS
| Product Name | Regulatory Agency | APIMF/ASMF/DMF number assigned by Regulatory Agency by Regulatory Agency |
Status |
| Anti-Malaria | |||
| Amodiaquine Hydrochloride | WHO Geneva |
APIMF 134/WHOAPI 134 |
Approved |
| Artemether | WHO Geneva |
WHOAPI 138 |
Approved |
| Artesunate | WHO Geneva |
APIMF 135/WHOAPI 135 |
Approved |
| Dihydroartemisinin | WHO-Geneva and EMA |
WHOAPI 151and EMEA/ASMF/01008 |
Approved |
| Lumefantrine | WHO Geneva |
APIMF 100/WHOAPI 100 |
Approved |
| Primaquine Phosphate | WHO Geneva |
APIMF 380 |
Approved |
| Piperaquine Phosphate | WHO-Geneva and EMA |
WHOAPI 149 and EMEA/ASMF/01007 | Approved |
| Pyrimethamine | WHO-Geneva |
WHOAPI 360 |
Approved |
| Pyronaridine Tetraphosphate | WHO-Geneva |
WHOAPI 405 |
Approved |
| Sulfadoxine | WHO-Geneva |
WHOAPI 356 |
Approved |
EDQM |
CEP 2021-186 / Sulfadoxine |
Approved |
|
| Anti-Retroviral | |||
| Dolutegravir (Sodium) | WHO-Geneva |
WHOAPI 386 |
Approved |
| Efavirenz | WHO-Geneva |
WHOAPI 318 |
Approved |
| Emtricitabine | WHO-Geneva |
WHOAPI 314 |
Approved |
| Tenofovir Disoproxil Fumarate | WHO-Geneva |
APIMF 204/WHOAPI 204 |
Approved |
| Anti-Hypertensive | |||
| Furosemide (Ph.Eur.) | EDQM |
CEP 2019-063 / Furosemide |
Approved |
| Anti-Inflammatory | |||
| Nimesulide (Ph.Eur.) | EDQM |
CEP 2011-310/ Nimesulide |
Approved |
| Anti-Convulsant | |||
| Pregabalin (Ph.Eur.) | EDQM | CEP 2020-016/Pregabalin | Approved |
| Anti-Viral | |||
| Aciclovir (Ph.Eur.) | EDQM |
CEP 2020-314 / Aciclovir |
Approved |
| Anti-Rheumatic Arthritis Agent | |||
| Hydroxychloroquine sulfate (Ph.Eur.) | EDQM |
CEP 2019-151 / Hydroxychloroquine sulfate |
Approved |
| Anti-Bacterial | |||
| Nitrofurantoin (Ph.Eur.) | EDQM | CEP 2020-202 / Nitrofurantoin | Approved |
| Nitrofurantoin ‘Macrocrystals’ (Ph.Eur.) | EDQM | CEP 2020-236 / Nitrofurantoin ‘Macrocrystals’ | Approved |
| Planned Submissions: | |||
| Anti-Hypertensive | |||
| Bisoprolol Fumarate (Ph.Eur.) | EDQM |
- |
Under Preparation |
