Helsinn Birex Pharmaceuticals is a finished-dose manufacturer based in Ireland. It appears in 86 regulatory filings across 15 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), AEMPS (ES) and EMA. Its GMP standing is certified by EMA, MFDS (Korea) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 15 July 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Dublin 15, United Arab Emirates | Not on file |
| Dublin, United Arab Emirates | Not on file |
| Ireland, Ireland | 3003724414 |
| DUBLIN, Ireland | Not on file |
| Dublin 15, Ireland | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 20 | None |
| AEMPS (ES) | 14 | None |
| EMA | 12 | 2 |
| FAMHP (BE) | 10 | None |
| INFARMED (PT) | 9 | None |
| MPA (SE) | 7 | None |
| MFDS (Korea) | None | 2 |
| ANVISA (Brazil) | None | 2 |
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