AlfaSigma is a finished-dose manufacturer based in Italy. It appears in 883 regulatory filings across 23 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and AEMPS (ES). Its GMP standing is certified by ANVISA (Brazil), EMA and MINPROMTORG (RU), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 26 January 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Alanno, United Arab Emirates | Not on file |
| Zofingen, Switzerland | Not on file |
| Campredo, Spain | Not on file |
| PESCARA, Italy | Not on file |
| ALANNO, Italy | Not on file |
| Italy, Italy | 3002808171 |
4 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 497 | None |
| EMA | 160 | 3 |
| AEMPS (ES) | 43 | None |
| ANSM (FR) | 37 | None |
| INFARMED (PT) | 35 | None |
| FAMHP (BE) | 18 | None |
| ANVISA (Brazil) | None | 5 |
| MINPROMTORG (RU) | None | 2 |
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
| EAEU_EEC | None | 1 |
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