Alpex Pharma is a contract manufacturer based in Switzerland. It appears in 17 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, URPL (PL) and NPRA (MY). Its GMP standing is certified by US FDA and FDA (GH). Its most recent recorded inspection, by US FDA, closed on 14 December 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Switzerland, Switzerland | 3004311700 |
| Mezzovico-Vira, Switzerland | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 7 | None |
| URPL (PL) | 5 | None |
| NPRA (MY) | 2 | None |
| ANSM (FR) | 2 | None |
| UZPHARM (UZ) | 1 | None |
| US FDA | None | 1 |
| FDA (GH) | None | 1 |
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