Amneal is a finished-dose manufacturer based in India. It holds one active US drug master file. Its filings concentrate with US FDA, INFARMED (PT) and MPA (SE). Its GMP standing is certified by US FDA, EMA and TMDA (TZ). Its most recent recorded inspection, by US FDA, closed on 28 March 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Jadcherla, United Arab Emirates | Not on file |
| Dist.-Ahmedabad, United Arab Emirates | Not on file |
| Mehsana, India | 3018907202 |
| Ahmedabad, India | 3017573557 |
| Ahmedabad, India | 3030461061 |
| Ahmedabad, India | 3029456823 |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Glatiramer | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 459 | 6 |
| INFARMED (PT) | 88 | None |
| MPA (SE) | 69 | None |
| DIGEMAPS (DO) | 11 | None |
| ARCSA (EC) | 7 | None |
| JFDA (JO) | 7 | None |
| EMA | None | 1 |
| TMDA (TZ) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2017 | $0 | Not reported | Not reported |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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