Laboratorio Reig Jofre is a finished-dose manufacturer based in Spain. It appears in 391 regulatory filings across 14 regulators, without an active US DMF or CEP on file. Its filings concentrate with AEMPS (ES), EMA and AIFA (IT). Its GMP standing is certified by AEMPS (ES), ANVISA (Brazil) and EAEU_EEC, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 23 June 2023 as OAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Barcelona, United Arab Emirates | Not on file |
| Barcelona, United Arab Emirates | Not on file |
| BARCELONA, Spain | Not on file |
| Toledo, Spain | Not on file |
| Barcelona, Spain | Not on file |
| Toledo, Spain | Not on file |
2 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| AEMPS (ES) | 167 | 3 |
| EMA | 104 | 1 |
| AIFA (IT) | 51 | None |
| INFARMED (PT) | 26 | None |
| ANSM (FR) | 15 | None |
| MPA (SE) | 9 | None |
| ANVISA (Brazil) | None | 1 |
| EAEU_EEC | None | 1 |
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