Tiofarma is a finished-dose manufacturer based in Netherlands. It appears in 82 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, FAMHP (BE) and MPA (SE). Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 22 September 2023 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Netherlands, Netherlands | 3013984264 |
| Oud-Beijerland, Netherlands | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 45 | 1 |
| FAMHP (BE) | 14 | None |
| MPA (SE) | 7 | None |
| BFARM (DE) | 5 | None |
| DMP (NO) | 4 | None |
| INFARMED (PT) | 2 | None |
| US FDA | None | 1 |
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