Fareva Unterach is a finished-dose manufacturer based in Austria. It appears in 242 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE), UZPHARM (UZ) and MINSA (CR). Its GMP standing is certified by NCELS (KZ), ANVISA (Brazil) and EMA. Its most recent recorded inspection, by US FDA, closed on 2 June 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Unterach, United Arab Emirates | Not on file |
| UNTERACH AM ATTERSEE, Austria | Not on file |
| Austria, Austria | 3002829723 |
| Oberoesterreich, Austria | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EDE (AE) | 202 | None |
| UZPHARM (UZ) | 12 | None |
| MINSA (CR) | 10 | None |
| FDA (GH) | 8 | None |
| NAFDAC (NG) | 3 | None |
| NPRA (MY) | 2 | None |
| NCELS (KZ) | None | 2 |
| ANVISA (Brazil) | None | 1 |
| EMA | None | 1 |
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