Fertin Pharma A/S is a finished-dose manufacturer based in Denmark. It holds 2 active US drug master files and one valid CEP across a filed portfolio of 2 molecules. Its filings concentrate with EMA, MPA (SE) and DIGEMAPS (DO). Its GMP standing is certified by ANVISA (Brazil), HSA (SG) and EMA. Its most recent recorded inspection, by US FDA, closed on 4 November 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| VEJLE, Denmark | Not on file |
| Denmark, Denmark | 3003029369 |
| Molecule | Regulators | Docs |
|---|---|---|
| Nicotine | US FDA | 2 |
| Nicotine Resinate | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 12 | 1 |
| MPA (SE) | 7 | None |
| DIGEMAPS (DO) | 4 | None |
| ANSM (FR) | 4 | None |
| EDA (EG) | 2 | None |
| US FDA | 1 | None |
| ANVISA (Brazil) | None | 3 |
| HSA (SG) | None | 2 |
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