Merck Serono is a finished-dose manufacturer based in Switzerland. It appears in 151 regulatory filings across 22 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), ARCSA (EC) and EDA (EG). Its GMP standing is certified by MHRA (UK), EMA and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 2 May 2023 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| CH- 1170 Aubonne, United Arab Emirates | Not on file |
| Modugno (BA), United Arab Emirates | Not on file |
| Switzerland, Switzerland | 3002807447 |
| AUBONNE, Switzerland | Not on file |
| Switzerland, Switzerland | 3003131678 |
| Aubonne, Switzerland | Not on file |
3 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 28 | None |
| ARCSA (EC) | 18 | None |
| EDA (EG) | 13 | None |
| SFDA (Saudi Arabia) | 10 | None |
| ANSM (FR) | 9 | None |
| ANPP (DZ) | 8 | None |
| MHRA (UK) | None | 4 |
| EMA | None | 2 |
| ANVISA (Brazil) | None | 2 |
| NAFDAC (NG) | None | 1 |
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