Cyndea Pharma, S.L is a finished-dose manufacturer based in Spain. It appears in 28 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), EFDA (ET) and NAFDAC (NG). Its GMP standing is certified by ANVISA (Brazil), AEMPS (ES) and NAFDAC (NG), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 10 March 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Olvega, United Arab Emirates | Not on file |
| Soria, United Arab Emirates | Not on file |
| OLVEGA, Spain | Not on file |
| Soria, Spain | Not on file |
| Olvega, Spain | Not on file |
| Spain, Spain | 3008190361 |
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 7 | None |
| EFDA (ET) | 4 | None |
| NAFDAC (NG) | 4 | 1 |
| INVIMA (CO) | 3 | None |
| DIGEMAPS (DO) | 3 | None |
| MINSA (CR) | 3 | None |
| ANVISA (Brazil) | None | 1 |
| AEMPS (ES) | None | 1 |
| EMA | None | 1 |
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