Merck Sharp & Dohme Farmaceutica Ltda is an API and finished-dose manufacturer based in United States. It holds one active US drug master file. Its filings concentrate with ANVISA (Brazil), US FDA and BOMRA (BW). Its GMP standing is certified by ANVISA (Brazil), US FDA and MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 22 January 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Singapore, United Arab Emirates | Not on file |
| São Paulo, Brazil | Not on file |
| APARECIDA DE GOIÂNIA, Brazil | Not on file |
| CAMPINAS, Brazil | Not on file |
| SAO PAULO, Brazil | Not on file |
| Ireland, Ireland | 3008694906 |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Betamethasone | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ANVISA (Brazil) | 242 | 7 |
| US FDA | 89 | 5 |
| BOMRA (BW) | 5 | None |
| ARCSA (EC) | 4 | None |
| DIGEMAPS (DO) | 1 | None |
| MFDS (Korea) | None | 2 |
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