Lek Pharmaceuticals D.D
United Arab Emirates 2 duplicate records merged Updated 9 July 2026
Lek Pharmaceuticals D.D is an API manufacturer based in United Arab Emirates. 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 RAMA (GE). Its GMP standing is certified by ANVISA (Brazil), NCELS (KZ) and EAEU_EEC, among 5 authorities. Customs aggregates show $98K of exports covering 3 molecules to 1 destination in 2022.
264
filings
across 13 regulators
These figures were checked against the regulators' own files on 25 July 2026
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.
Registered plants
| 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 |
| D.D. Ljubljana, Slovenia | Not on file |
| PREVALJE, Slovenia | Not on file |
What they file, and where
Show all 24 molecules on file
| 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
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| DIGEMAPS (DO) | 126 | None |
| MINSA (CR) | 46 | None |
| RAMA (GE) | 28 | None |
| ARCSA (EC) | 23 | None |
| NAFDAC (NG) | 15 | 1 |
| DAV (Vietnam) | 9 | None |
| ANVISA (Brazil) | None | 8 |
| NCELS (KZ) | None | 6 |
| EAEU_EEC | None | 2 |
| EMA | None | 1 |
Scale
| Year | Revenue | Exports | Destinations |
| 2022 | Not reported | $98K | 1 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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Open risk flags
- 1 active litigation matter is on record.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates
- Customs aggregates
- Export values, molecule and destination counts