Novartis Pharma Produktions is a finished-dose manufacturer based in Germany. It appears in 40 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), ARCSA (EC) and NPRA (MY). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and MFDS (Korea), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 11 July 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| WEHR/BADEN, Germany | Not on file |
| Germany, Germany | 3000978864 |
| Wehr, Germany | Not on file |
| Baden-Wuerttemberg, Germany | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| DIGEMAPS (DO) | 16 | None |
| ARCSA (EC) | 11 | None |
| NPRA (MY) | 7 | None |
| NAFDAC (NG) | 3 | None |
| MINSA (CR) | 3 | None |
| ZLG (DE) | None | 4 |
| ANVISA (Brazil) | None | 3 |
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
| NCELS (KZ) | None | 1 |
| EMA | None | 1 |
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