Sintetica is a finished-dose manufacturer based in Germany. It appears in 238 regulatory filings across 13 regulators, without an active US DMF or CEP on file. Its filings concentrate with SWISSMEDIC (CH), EMA and MPA (SE). Its GMP standing is certified by ZLG (DE), EMA and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 16 May 2023 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Mendrisio, United Arab Emirates | Not on file |
| Switzerland, Switzerland | 3008535840 |
| Mendrisio, Switzerland | Not on file |
| North Rhine-Westphalia, Germany | Not on file |
| Aschaffenburg, Germany | Not on file |
| Muenster, Germany | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| SWISSMEDIC (CH) | 150 | None |
| EMA | 30 | 1 |
| MPA (SE) | 16 | None |
| URPL (PL) | 10 | None |
| DMP (NO) | 9 | None |
| DKMA (DK) | 7 | None |
| ZLG (DE) | None | 6 |
| ANVISA (Brazil) | None | 1 |
| US FDA | None | 1 |
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