Hovione Farmaciência is an API and finished-dose manufacturer based in Portugal. It holds 26 active US drug master files and 9 valid CEPs across a filed portfolio of 8 molecules. Its filings concentrate with MINSA (CR) and INVIMA (CO). Its GMP standing is certified by EMA and INFARMED (PT).
| Site | FDA FEI |
|---|---|
| Loures, Portugal | Not on file |
| Lumiar, Portugal | Not on file |
| LOURES, Portugal | Not on file |
| Lisboa, Portugal | Not on file |
| Lisboa, Portugal | Not on file |
| Loures, Portugal | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Fluticasone Propionate | EDQM, SFDA (Saudi Arabia), US FDA | 9 |
| Minocycline | EDQM, US FDA | 6 |
| Mometasone Furoate | EDQM, US FDA | 6 |
| Betamethasone | US FDA | 4 |
| Doxycycline | US FDA | 4 |
| Salmeterol | EDQM, US FDA | 4 |
| Halobetasol Propionate | US FDA | 2 |
| Fluticasone Furoate | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 5 | None |
| INVIMA (CO) | 3 | None |
| EMA | None | 5 |
| INFARMED (PT) | None | 4 |
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