Kedrion is a finished-dose manufacturer based in Italy. It appears in 277 regulatory filings across 23 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and INFARMED (PT). Its GMP standing is certified by EMA, ANVISA (Brazil) and MINPROMTORG (RU), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 30 April 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Gallicano, United Arab Emirates | Not on file |
| Sant'antimo (NA), United Arab Emirates | Not on file |
| GALLICANO, Italy | Not on file |
| SIENA, Italy | Not on file |
| SANT'ANTIMO, Italy | Not on file |
| BARGA, Italy | Not on file |
6 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 112 | None |
| EMA | 49 | 5 |
| INFARMED (PT) | 23 | None |
| RAMA (GE) | 14 | None |
| DPM (TN) | 9 | None |
| DAV (Vietnam) | 9 | None |
| ANVISA (Brazil) | None | 3 |
| MINPROMTORG (RU) | None | 2 |
| US FDA | None | 1 |
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