Idt Biologika is a finished-dose manufacturer based in Germany. It appears in 52 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with MPA (SE), NCELS (KZ) and MINSA (CR). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and MFDS (Korea), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 8 September 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| DESSAU-ROSSLAU, Germany | Not on file |
| Germany, Germany | 3005001757 |
| Dessau Rosslau, Germany | Not on file |
| Dessau-Rosslau, Nigeria | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| MPA (SE) | 11 | None |
| NCELS (KZ) | 10 | 1 |
| MINSA (CR) | 8 | None |
| ARCSA (EC) | 7 | None |
| DIGEMAPS (DO) | 7 | None |
| NAFDAC (NG) | 6 | 1 |
| ZLG (DE) | None | 6 |
| ANVISA (Brazil) | None | 4 |
| MFDS (Korea) | None | 2 |
| EMA | None | 1 |
| US FDA | None | 1 |
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