Haleon Ireland Dungarvan is a finished-dose manufacturer based in Ireland. It appears in 165 regulatory filings across 13 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), FAMHP (BE) and EDE (AE). Its GMP standing is certified by EMA, ANVISA (Brazil) and US FDA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 23 August 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Dungarvan, United Arab Emirates | Not on file |
| DUNGARVAN, Ireland | Not on file |
| Co. Waterford, Ireland | Not on file |
| Ireland, Ireland | 3003721894 |
| Regulator | Filings | GMP certificates |
|---|---|---|
| NPRA (MY) | 109 | None |
| FAMHP (BE) | 10 | None |
| EDE (AE) | 10 | None |
| AEMPS (ES) | 10 | None |
| AIFA (IT) | 10 | None |
| EMA | 4 | 2 |
| ANVISA (Brazil) | None | 2 |
| US FDA | None | 1 |
| NCELS (KZ) | None | 1 |
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