Takeda Manufacturing Austria is a finished-dose manufacturer based in Austria. It appears in 264 regulatory filings across 20 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EDE (AE) and FAMHP (BE). Its GMP standing is certified by EMA, EAEU_EEC and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 24 April 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Lessines, United Arab Emirates | Not on file |
| IndustriestraBe 67 - Vienna, United Arab Emirates | Not on file |
| Lange Allee 24 - Vienna, United Arab Emirates | Not on file |
| VIENNA, Austria | Not on file |
| Austria, Austria | 3004073331 |
| Austria, Austria | 3003608834 |
6 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 36 | None |
| EDE (AE) | 34 | None |
| FAMHP (BE) | 33 | None |
| EMA | 28 | 10 |
| SFDA (Saudi Arabia) | 22 | None |
| MPA (SE) | 19 | None |
| EAEU_EEC | None | 4 |
| ANVISA (Brazil) | None | 4 |
| US FDA | None | 1 |
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