Bayer De Mexico, S.A. De C.V is a finished-dose manufacturer based in Mexico. It appears in 34 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with COFEPRIS (MX), MINSA (CR) and INVIMA (CO). Its GMP standing is certified by COFEPRIS (MX), ANVISA (Brazil) and EMA. Its most recent recorded inspection, by US FDA, closed on 9 December 2022 as VAI. Customs aggregates show $2.0M of exports covering 9 molecules to 4 destinations in 2024.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Lerma, Colombia | Not on file |
| LERMA, Mexico | Not on file |
| Ixtaczoquitlán, Mexico | Not on file |
| Mexico, Mexico | 3002807925 |
| Mexico, Mexico | 3002806479 |
| Lerma, Mexico | Not on file |
2 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| COFEPRIS (MX) | 18 | 8 |
| MINSA (CR) | 9 | None |
| INVIMA (CO) | 7 | None |
| ANVISA (Brazil) | None | 3 |
| EMA | None | 2 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2024 | Not reported | $2.0M | 4 |
| 2023 | Not reported | $119.1M | 18 |
| 2022 | Not reported | $96.9M | 20 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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