Genentech is a finished-dose manufacturer based in United States. It appears in 1,415 regulatory filings across 29 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and MPA (SE). Its GMP standing is certified by ANSM (FR), US FDA and HSA (SG), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 21 April 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Indianapolis, United Arab Emirates | Not on file |
| Mannheim, United Arab Emirates | Not on file |
| Boulogne Billancourt, France | Not on file |
| CASABLANCA, Morocco | Not on file |
| Ota, Portugal | Not on file |
| SOUTH SAN FRANCISCO, United States | Not on file |
3 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 192 | None |
| EMA | 162 | 1 |
| MPA (SE) | 129 | None |
| FAMHP (BE) | 125 | None |
| INFARMED (PT) | 125 | None |
| US FDA | 83 | 3 |
| ANSM (FR) | None | 5 |
| HSA (SG) | None | 2 |
| ANVISA (Brazil) | None | 2 |
| NCELS (KZ) | None | 1 |
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