Takeda Austria is a finished-dose manufacturer based in Austria. It holds one valid CEP. Its filings concentrate with EMA, RAMA (GE) and ARCSA (EC). Its GMP standing is certified by ANVISA (Brazil), MFDS (Korea) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 11 September 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Linz, United Arab Emirates | Not on file |
| LINZ, Austria | Not on file |
| Austria, Austria | 3001157285 |
| Oberösterreich, Austria | Not on file |
| Oberoesterreich, Austria | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Deproteinised Hemoderivative Of Calf Blood | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 10 | 2 |
| RAMA (GE) | 3 | None |
| ARCSA (EC) | 1 | None |
| INVIMA (CO) | 1 | None |
| MINSA (CR) | 1 | None |
| ANVISA (Brazil) | None | 3 |
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
| EAEU_EEC | None | 1 |
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