Janssen-Cilag Farmaceutica Ltda is an API and finished-dose manufacturer based in United States. It holds 5 active US drug master files across a filed portfolio of 3 molecules. Its filings concentrate with ANVISA (Brazil), US FDA and INFARMED (PT). Its GMP standing is certified by US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 7 October 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Belgium, Belgium | 3002807336 |
| Belgium, Belgium | 3002807337 |
| Belgium, Belgium | 3002807334 |
| São Paulo, Brazil | Not on file |
| SAO PAULO, Brazil | Not on file |
| SÃO JOSÉ DOS CAMPOS, Brazil | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Methylphenidate | US FDA | 2 |
| Rivaroxaban | US FDA | 2 |
| Rilpivirine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ANVISA (Brazil) | 316 | 5 |
| US FDA | 220 | 7 |
| INFARMED (PT) | 122 | None |
| DIGEMAPS (DO) | 6 | None |
| ARCSA (EC) | 5 | None |
| SFDA (Saudi Arabia) | 5 | None |
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