Fresenius Kabi Deutschland is a finished-dose manufacturer based in Germany. It appears in 157 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, DAV (Vietnam) and BFARM (DE). Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 19 October 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| FRIEDBERG, Germany | Not on file |
| Hesse, Germany | Not on file |
| Friedberg (Hessen), Germany | Not on file |
| Germany, Germany | 3002851530 |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 133 | 3 |
| DAV (Vietnam) | 20 | None |
| BFARM (DE) | 4 | None |
| ZLG (DE) | None | 12 |
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