Janssen-Cilag Manufacturing is a finished-dose manufacturer based in Puerto Rico. It appears in 36 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), ARCSA (EC) and NPRA (MY). Its GMP standing is certified by NAFDAC (NG), ANVISA (Brazil) and NCELS (KZ).
| Site | FDA FEI |
|---|---|
| Gurabo, United Arab Emirates | Not on file |
| Puerto Rico, Nigeria | Not on file |
| GURABO, Puerto Rico | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| DIGEMAPS (DO) | 13 | None |
| ARCSA (EC) | 8 | None |
| NPRA (MY) | 6 | None |
| INVIMA (CO) | 5 | None |
| NAFDAC (NG) | 2 | 1 |
| EDE (AE) | 2 | None |
| ANVISA (Brazil) | None | 1 |
| NCELS (KZ) | None | 1 |
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