Novartis Farmacéutica, S. A is a finished-dose manufacturer based in Spain. It appears in 270 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with AEMPS (ES), EMA and ARCSA (EC). Its GMP standing is certified by AEMPS (ES), NAFDAC (NG) and EMA.
| Site | FDA FEI |
|---|---|
| Barcelona, Spain | Not on file |
| Barcelona, Spain | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| AEMPS (ES) | 222 | 1 |
| EMA | 31 | 1 |
| ARCSA (EC) | 13 | None |
| NAFDAC (NG) | 3 | 1 |
| MINSA (CR) | 1 | None |
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