Norgine Healthcare is a finished-dose manufacturer based in United Kingdom. It appears in 480 regulatory filings across 18 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, MHRA (UK) and AIFA (IT). Its GMP standing is certified by MHRA (UK), US FDA and EMA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 20 June 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hengoed, United Arab Emirates | Not on file |
| Luzern, Switzerland | Not on file |
| NEWPORT, United Kingdom | Not on file |
| HENGOED, United Kingdom | Not on file |
| United Kingdom, United Kingdom | 3005202761 |
| Amsterdam, Netherlands | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 121 | 1 |
| MHRA (UK) | 108 | 5 |
| AIFA (IT) | 78 | None |
| SWISSMEDIC (CH) | 36 | None |
| AEMPS (ES) | 27 | None |
| FAMHP (BE) | 24 | None |
| US FDA | None | 1 |
| EAEU_EEC | None | 1 |
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