Lek is a finished-dose manufacturer based in Poland. It appears in 73 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), RCETH (BY) and MINSA (CR). Its GMP standing is certified by EMA, NCELS (KZ) and NAFDAC (NG), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 26 July 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| strykow, United Arab Emirates | Not on file |
| Podlipie Street 95 Strykow Poland, Nigeria | Not on file |
| STRYKÓW, Poland | Not on file |
| Warszawa, Poland | Not on file |
| Strykow, Poland | Not on file |
| Slovenia, Slovenia | 3002807460 |
1 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 20 | None |
| RCETH (BY) | 18 | None |
| MINSA (CR) | 16 | None |
| NAFDAC (NG) | 11 | 2 |
| NCELS (KZ) | 3 | 4 |
| INVIMA (CO) | 2 | None |
| EMA | None | 8 |
| US FDA | None | 1 |
| ANVISA (Brazil) | None | 1 |
Choose your molecules and target markets. Lek comes back tiered against every other supplier able to file there.
Start for free