Alkermes is a finished-dose manufacturer based in United States. It holds one active US drug master file across a filed portfolio of 2 molecules. Its filings concentrate with US FDA, ARCSA (EC) and DIGEMAPS (DO). Its GMP standing is certified by ANVISA (Brazil), EAEU_EEC and MHRA (UK), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 19 October 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| WILMINGTON, United States | Not on file |
| WILMINGTON, United States | Not on file |
| Wilmington, United States | 1000142940 |
| Molecule | Regulators | Docs |
|---|---|---|
| Sirolimus | US FDA | 1 |
| Ｍｅｄｉｓｏｒｂ７５２５Ｄｌｊｎ１ | PMDA (Japan) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 10 | 1 |
| ARCSA (EC) | 3 | None |
| DIGEMAPS (DO) | 2 | None |
| INVIMA (CO) | 2 | None |
| NCELS (KZ) | 1 | None |
| ANVISA (Brazil) | None | 1 |
| EAEU_EEC | None | 1 |
| MHRA (UK) | None | 1 |
| MINPROMTORG (RU) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2025 | $1.5B | Not reported | Not reported |
| 2024 | $1.6B | Not reported | Not reported |
| 2023 | $1.7B | Not reported | Not reported |
Export figures are customs aggregates. We do not publish the identity of any buyer.
Choose your molecules and target markets. Alkermes comes back tiered against every other supplier able to file there.
Start for free