Astellas Ireland is an API and finished-dose manufacturer based in Ireland. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with URPL (PL), AIFA (IT) and US FDA. Its GMP standing is certified by ZLG (DE), US FDA and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 6 June 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Killorglin, United Arab Emirates | Not on file |
| Wallisellen, Switzerland | Not on file |
| Offenbach Am Main, Germany | Not on file |
| Hassia, Germany | Not on file |
| Munich, Germany | Not on file |
| ADDLESTONE, United Kingdom | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Famotidine | US FDA | 1 |
| Tacrolimus | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| URPL (PL) | 77 | None |
| AIFA (IT) | 71 | None |
| US FDA | 68 | 4 |
| MHRA (UK) | 61 | None |
| Health Canada | 57 | None |
| INFARMED (PT) | 57 | None |
| ZLG (DE) | None | 6 |
| EMA | None | 3 |
| ANVISA (Brazil) | None | 2 |
| MFDS (Korea) | None | 2 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2024 | $250.0B | Not reported | Not reported |
| 2023 | $445.6M | Not reported | Not reported |
| 2022 | $220.0B | Not reported | Not reported |
Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.
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