Lek Pharmaceuticals is an API and finished-dose manufacturer based in Slovenia. It holds 26 active US drug master files and 10 valid CEPs across a filed portfolio of 24 molecules. Its filings concentrate with DIGEMAPS (DO), MINSA (CR) and ARCSA (EC). Its GMP standing is certified by ANVISA (Brazil), NCELS (KZ) and EMA, among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 26 July 2024 as NAI. Customs aggregates show $98K of exports covering 3 molecules to 1 destination in 2022.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Lendava, United Arab Emirates | Not on file |
| Ljubljana, United Arab Emirates | Not on file |
| Menges, United Arab Emirates | Not on file |
| Ljubljana, United Arab Emirates | Not on file |
| strykow, United Arab Emirates | Not on file |
| Ljubljana Slovenia, Nigeria | Not on file |
10 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Potassium Clavulanate | EDQM | 7 |
| Clavulanic Acid | US FDA | 4 |
| Tacrolimus | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Mycophenolate Mofetil | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Atorvastatin | SFDA (Saudi Arabia), US FDA | 2 |
| Gentamicin | EDQM, US FDA | 2 |
| Potassium | US FDA | 2 |
| Rosuvastatin | US FDA | 2 |
| Apremilast | US FDA | 1 |
| Bromocriptine | US FDA | 1 |
| Candesartan Cilexetil | SFDA (Saudi Arabia) | 1 |
| Dolutegravir | US FDA | 1 |
| Entecavir | US FDA | 1 |
| Esomperazole | SFDA (Saudi Arabia) | 1 |
| Ferric Carboxymaltose | US FDA | 1 |
| Ferumoxytol | US FDA | 1 |
| Lithium Carbonate | SFDA (Saudi Arabia) | 1 |
| Lithium Cation | US FDA | 1 |
| Silver Sulfadiazine | US FDA | 1 |
| Sugammadex | US FDA | 1 |
| Tamsulosin | US FDA | 1 |
| Ticagrelor | US FDA | 1 |
| Vancomycin | US FDA | 1 |
| Vortioxetine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| DIGEMAPS (DO) | 126 | None |
| MINSA (CR) | 68 | None |
| ARCSA (EC) | 48 | None |
| UZPHARM (UZ) | 47 | None |
| RAMA (GE) | 28 | None |
| NAFDAC (NG) | 26 | 4 |
| ANVISA (Brazil) | None | 17 |
| NCELS (KZ) | None | 13 |
| EMA | None | 13 |
| EAEU_EEC | None | 2 |
| US FDA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2022 | Not reported | $98K | 1 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
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