Rottendorf Pharma is a finished-dose manufacturer based in Germany. It appears in 7 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EMA, among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 14 March 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Ennigerloh, United Arab Emirates | Not on file |
| North Rhine-Westphalia, Germany | Not on file |
| ENNIGERLOH, Germany | Not on file |
| Germany, Germany | 3003732290 |
| Beckum, Germany | Not on file |
| Ostenfelder Strabe 51-61 Ennlgerloh, Nigeria | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| NAFDAC (NG) | 7 | 1 |
| ZLG (DE) | None | 12 |
| ANVISA (Brazil) | None | 11 |
| EMA | None | 2 |
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
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