Catalent Germany Schorndorf is a finished-dose manufacturer based in Germany. It appears in 20 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE), INVIMA (CO) and MINSA (CR). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 17 March 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| 73614 Schorndorf, United Arab Emirates | Not on file |
| 73614 Schorndorf, United Arab Emirates | Not on file |
| SCHORNDORF, Germany | Not on file |
| Germany, Germany | 3003831171 |
| Baden-Wuerttemberg, Germany | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EDE (AE) | 7 | None |
| INVIMA (CO) | 5 | None |
| MINSA (CR) | 3 | None |
| NAFDAC (NG) | 2 | None |
| NPRA (MY) | 2 | None |
| UZPHARM (UZ) | 1 | None |
| ZLG (DE) | None | 8 |
| ANVISA (Brazil) | None | 5 |
| EMA | None | 2 |
| NCELS (KZ) | None | 1 |
| EAEU_EEC | None | 1 |
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