Bayer Weimar Gmbh Und is a finished-dose manufacturer based in Germany. It appears in 26 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), UZPHARM (UZ) and MINSA (CR). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EMA. Its most recent recorded inspection, by US FDA, closed on 24 November 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Weimar, United Arab Emirates | Not on file |
| WEIMAR, Germany | Not on file |
| Weimar, Germany | Not on file |
| Germany, Germany | 3002808091 |
| Thuringia, Germany | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 8 | None |
| UZPHARM (UZ) | 8 | None |
| MINSA (CR) | 5 | None |
| NAFDAC (NG) | 4 | None |
| DAV (Vietnam) | 1 | None |
| ZLG (DE) | None | 6 |
| ANVISA (Brazil) | None | 3 |
| EMA | None | 1 |
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