Laboratorios Andrómaco is a finished-dose manufacturer based in Chile. It appears in 496 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with ISP (CL), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by ANVISA (Brazil) and ISP (CL).
| Site | FDA FEI |
|---|---|
| SANTIAGO, Chile | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| ISP (CL) | 245 | 1 |
| ARCSA (EC) | 91 | None |
| MINSA (CR) | 82 | None |
| ANMAT (AR) | 36 | None |
| INHRR (VE) | 22 | None |
| INFARMED (PT) | 16 | None |
| ANVISA (Brazil) | None | 1 |
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