Organon Pharma (Uk) is a finished-dose manufacturer based in United Kingdom. It appears in 498 regulatory filings across 10 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), BPOM (ID) and EMA. Its GMP standing is certified by BPOM (ID), ANVISA (Brazil) and MHRA (UK), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 13 June 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Cramlington, United Arab Emirates | Not on file |
| Mexico D.F., Colombia | Not on file |
| CRAMLINGTON, United Kingdom | Not on file |
| United Kingdom, United Kingdom | 3002807653 |
| CRAMLINGTON, United Kingdom | Not on file |
| -, Indonesia | Not on file |
1 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| MHRA (UK) | 239 | 2 |
| BPOM (ID) | 153 | 22 |
| EMA | 34 | None |
| NPRA (MY) | 23 | None |
| SFDA (Saudi Arabia) | 13 | None |
| ARCSA (EC) | 12 | None |
| ANVISA (Brazil) | None | 3 |
| MFDS (Korea) | None | 2 |
| EAEU_EEC | None | 1 |
| US FDA | None | 1 |
| NAFDAC (NG) | None | 1 |
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