Catalent Germany Eberbach is a finished-dose manufacturer based in Germany. It appears in 54 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), ARCSA (EC) and EDE (AE). Its GMP standing is certified by ANVISA (Brazil), ZLG (DE) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 2 February 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Eberbach, United Arab Emirates | Not on file |
| EBERBACH, Germany | Not on file |
| Baden-Wuerttemberg, Germany | Not on file |
| Germany, Germany | 3002808098 |
| Regulator | Filings | GMP certificates |
|---|---|---|
| DIGEMAPS (DO) | 11 | None |
| ARCSA (EC) | 10 | None |
| EDE (AE) | 8 | None |
| NPRA (MY) | 8 | None |
| MINSA (CR) | 7 | None |
| INVIMA (CO) | 5 | None |
| ANVISA (Brazil) | None | 7 |
| ZLG (DE) | None | 6 |
| EMA | None | 1 |
| EAEU_EEC | None | 1 |
| US FDA | None | 1 |
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