Suppliers / Lek Pharmaceuticals D.D

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.

26
active US DMFs
10
valid CEPs
6
registered plants
264
filings across 13 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
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

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
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 We do not publish the identity of any buyer.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