Antibioticos Do Brasil Ltda is an API and finished-dose manufacturer based in Mexico. It holds 5 active US drug master files and one valid CEP across a filed portfolio of 7 molecules. Its filings concentrate with ANVISA (Brazil), COFEPRIS (MX) and ARCSA (EC). Its GMP standing is certified by ANVISA (Brazil), EMA and COFEPRIS (MX), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 27 May 2022 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| COSMOPOLIS, Brazil | Not on file |
| Brazil, Brazil | 3004132818 |
| SUMARÉ, Brazil | Not on file |
| Cosmopolis Sao Paulo, Brasil, Colombia | Not on file |
| Coyoacán, Mexico | Not on file |
| Texcoco, Mexico | Not on file |
2 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Cefepime | SFDA (Saudi Arabia), US FDA | 2 |
| Amoxicillin | US FDA | 1 |
| Ampicillin | US FDA | 1 |
| Arginine | US FDA | 1 |
| Ceftazidime Pentahydrate With Sodium Carbonate For Injection | EDQM | 1 |
| Ceftobiprole Medocaril Sodium | SFDA (Saudi Arabia) | 1 |
| Cephalexin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ANVISA (Brazil) | 137 | 6 |
| COFEPRIS (MX) | 9 | 2 |
| ARCSA (EC) | 8 | None |
| INVIMA (CO) | 7 | 1 |
| DIGEMAPS (DO) | 5 | None |
| EMA | None | 4 |
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