Lek Pharmaceuticals D.D.

Overview

Lek Pharmaceuticals D.D. is a subsidiary of Novartis AG and is based in Slovenia. It is involved in the development, production, and marketing of generic drugs and pharmaceutical products in various therapeutic areas.

Therapeutic areas

API / Drug Master Files

Lek Pharmaceuticals D.D. holds 26 active (43 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• POTASSIUM CLAVULANATE DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1Active2023-09-27
• POTASSIUM CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1Active2023-01-17
• TACROLIMUS (PROCESS II)Active2020-08-06
• SUGAMMADEX SODIUMActive2019-06-05
• CLAVULANATE POTASSIUM DILUTED WITH SILICON DIOXIDE 1:1Active2018-05-17
• FERRIC CARBOXYMALTOSEActive2018-03-29
• APREMILASTActive2017-09-27
• VORTIOXETINE HYDROBROMIDEActive2017-03-01
• DOLUTEGRAVIR SODIUMActive2016-12-19
• ROSUVASTATIN CALCIUM (PROCESS C)Active2016-12-01
• CLAVULANATE POTASSIUM DILUTED WITH MICROCRYSTALLINE CELLULOSE 1:1Active2015-08-20
• TICAGRELORActive2015-02-06
• ENTECAVIR MONOHYDRATEActive2013-12-17
• FERUMOXYTOLActive2013-11-26
• MYCOPHENOLATE MOFETIL (PROCESS B), USPActive2011-09-27

Showing 15 of 43 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Lek Pharmaceuticals D.D. in our records. PharmaTek screens the full directory against live FDA enforcement data.