F.Hoffmann-La Roche is a finished-dose manufacturer based in Switzerland. It appears in 310 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with DAV (Vietnam), RAMA (GE) and ARCSA (EC). Its GMP standing is certified by EMA, TMDA (TZ) and NAFDAC (NG).
| Site | FDA FEI |
|---|---|
| Kaiseraugst, United Arab Emirates | Not on file |
| Kaiseraugst, United Arab Emirates | Not on file |
| Basel, United Arab Emirates | Not on file |
| KAISERAUGST, Switzerland | Not on file |
| Kaiseraugst, Switzerland | Not on file |
| Basel, Switzerland | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Cobimetinib Hemifumarate | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| DAV (Vietnam) | 147 | None |
| RAMA (GE) | 52 | None |
| ARCSA (EC) | 25 | None |
| MINSA (CR) | 25 | None |
| SFDA (Saudi Arabia) | 14 | None |
| EFDA (ET) | 13 | None |
| EMA | None | 18 |
| TMDA (TZ) | None | 2 |
| NAFDAC (NG) | None | 1 |
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