Italfarmaco is a finished-dose manufacturer based in Italy. It appears in 744 regulatory filings across 24 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), AEMPS (ES) and EMA. Its GMP standing is certified by EMA, ANVISA (Brazil) and AEMPS (ES). Its most recent recorded inspection, by US FDA, closed on 15 July 2021 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Milan, United Arab Emirates | Not on file |
| Madrid, United Arab Emirates | Not on file |
| Madrid, Spain | Not on file |
| Spain, Spain | 3007048260 |
| Alcobendas, Spain | Not on file |
| MILANO, Italy | Not on file |
5 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 350 | None |
| AEMPS (ES) | 174 | 1 |
| EMA | 87 | 2 |
| INFARMED (PT) | 46 | None |
| US FDA | 14 | None |
| MPA (SE) | 13 | None |
| ANVISA (Brazil) | None | 1 |
Choose your molecules and target markets. Italfarmaco comes back tiered against every other supplier able to file there.
Start for free