Laboratórios Sophia S.A. De C.V is a finished-dose manufacturer based in Mexico. It appears in 154 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), DIGEMAPS (DO) and INVIMA (CO). Its GMP standing is certified by COFEPRIS (MX) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 14 December 2018 as VAI. Customs aggregates show $194K of exports covering 7 molecules to 2 destinations in 2023.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Mexico, Mexico | 1000310459 |
| ZAPOPAN, Mexico | Not on file |
| Zapopan, Mexico | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 59 | None |
| DIGEMAPS (DO) | 40 | None |
| INVIMA (CO) | 28 | None |
| MINSA (CR) | 17 | None |
| ANMAT (AR) | 8 | None |
| COFEPRIS (MX) | 2 | 4 |
| ANVISA (Brazil) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2023 | Not reported | $194K | 2 |
| 2022 | Not reported | $98K | 1 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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