Amgen is a finished-dose manufacturer based in United States. It appears in 1,081 regulatory filings across 36 regulators, without an active US DMF or CEP on file. Its filings concentrate with Health Canada, INFARMED (PT) and US FDA. Its GMP standing is certified by EMA, US FDA and HSA (SG), among 8 authorities. Its most recent recorded inspection, by US FDA, closed on 6 November 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Breda, United Arab Emirates | Not on file |
| Thousan Oaks, United Arab Emirates | Not on file |
| Juncos, United Arab Emirates | Not on file |
| Dublin, United Arab Emirates | Not on file |
| Dublin, United Arab Emirates | Not on file |
| Risch, Switzerland | Not on file |
6 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| Health Canada | 308 | None |
| INFARMED (PT) | 86 | None |
| US FDA | 81 | 5 |
| ANSM (FR) | 71 | None |
| SWISSMEDIC (CH) | 64 | None |
| MHRA (UK) | 47 | 1 |
| EMA | None | 6 |
| HSA (SG) | None | 5 |
| EAEU_EEC | None | 4 |
| ANVISA (Brazil) | None | 4 |
| NCELS (KZ) | None | 1 |
| NAFDAC (NG) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2020 | $25.4B | Not reported | Not reported |
| 2019 | $23.4B | Not reported | Not reported |
| 2018 | $23.7B | Not reported | Not reported |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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