Leo Laboratories is a finished-dose manufacturer based in Ireland. It appears in 123 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), EMA and MINSA (CR). Its GMP standing is certified by EMA, MFDS (Korea) and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 24 June 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Dublin, United Arab Emirates | Not on file |
| DUBLIN, Ireland | Not on file |
| Ireland, Ireland | 3002807468 |
| Dublin 12, Ireland | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| MHRA (UK) | 62 | None |
| EMA | 22 | 3 |
| MINSA (CR) | 11 | None |
| DIGEMAPS (DO) | 8 | None |
| ARCSA (EC) | 7 | None |
| DMP (NO) | 4 | None |
| MFDS (Korea) | None | 2 |
| ANVISA (Brazil) | None | 2 |
| NAFDAC (NG) | None | 1 |
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