Msd International Gmbh (Puerto Rico Branch) is an API and finished-dose manufacturer based in Ireland. It appears in 8 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by EMA, ANVISA (Brazil) and HSA (SG), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 24 October 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Ireland, Ireland | 3017657338 |
| CLONMEL, Ireland | Not on file |
| Tipperary, Ireland | Not on file |
| Ireland, Ireland | 3002807560 |
| Carlow, Ireland | Not on file |
| Ireland, Ireland | 3002808087 |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Sitagliptin | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 8 | None |
| EMA | None | 20 |
| ANVISA (Brazil) | None | 6 |
| HSA (SG) | None | 6 |
| US FDA | None | 4 |
| MHRA (UK) | None | 4 |
| MFDS (Korea) | None | 2 |
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