Berlimed is a finished-dose manufacturer based in Spain. It appears in 31 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), MINSA (CR) and JFDA (JO). Its GMP standing is certified by ANVISA (Brazil), EMA and MINPROMTORG (RU), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 9 March 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Madrid, United Arab Emirates | Not on file |
| Alcala de Henares, United Arab Emirates | Not on file |
| MADRID, Spain | Not on file |
| Madrid, Spain | Not on file |
| Alcala De Henares, Spain | Not on file |
| Spain, Spain | 3004492234 |
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 12 | None |
| MINSA (CR) | 7 | None |
| JFDA (JO) | 2 | None |
| NCELS (KZ) | 2 | None |
| DIGEMAPS (DO) | 2 | None |
| ISP (CL) | 1 | None |
| ANVISA (Brazil) | None | 3 |
| EMA | None | 2 |
| MINPROMTORG (RU) | None | 1 |
| AEMPS (ES) | None | 1 |
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