BIAL - Portela & Ca is an API and finished-dose manufacturer based in Portugal. It holds 3 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with DIGEMAPS (DO), INFARMED (PT) and AIFA (IT). Its GMP standing is certified by INFARMED (PT) and EMA.
| Site | FDA FEI |
|---|---|
| S. Mamede do Coronado, United Arab Emirates | Not on file |
| Coronado (São Romão e São Mamede), Portugal | Not on file |
| São Mamede do Coronado, Portugal | Not on file |
| S. Mamede do Coronado, Portugal | Not on file |
| SÃO MAMEDE DO CORONADO, Portugal | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Opicapone | US FDA | 2 |
| Eslicarbazepine Acetate | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| DIGEMAPS (DO) | 360 | None |
| INFARMED (PT) | 148 | 6 |
| AIFA (IT) | 65 | None |
| FAMHP (BE) | 36 | None |
| MPA (SE) | 12 | None |
| MINSA (CR) | 8 | None |
| EMA | None | 1 |
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