Alkem Laboratories Limited

Overview

Alkem Laboratories Limited is a leading Indian pharmaceutical company engaged in the development, manufacturing, and commercialization of pharmaceutical products. It offers a broad range of generic medications and is also involved in the production of active pharmaceutical ingredients (APIs).

Therapeutic areas

API / Drug Master Files

Alkem Laboratories Limited holds 45 active (47 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.

• OLANZAPINEActive2026-03-31
• TICAGRELORActive2025-10-17
• ESLICARBAZEPINE ACETATEActive2025-01-06
• QUETIAPINE FUMARATE USPActive2024-09-27
• EZETIMIBE USPActive2024-05-22
• LURASIDONE HYDROCHLORIDEActive2024-03-27
• NEBIVOLOL HYDROCHLORIDEActive2024-03-15
• AZILSARTAN KAMEDOXOMILActive2023-09-12
• BEMPEDOIC ACIDActive2023-08-31
• LISDEXAETAMINE DIMESYLATEActive2023-08-03
• ESKETAMINE HYDROCHLORIDEActive2022-09-26
• SOLRIAETOL HYDROCHLORIDEActive2022-03-28
• CANNABIDIOLActive2022-02-08
• RITALINIC ACIDActive2021-12-21
• BIS-BOC-LISDEXAETAMINEActive2021-10-25

Showing 15 of 47 Drug Master Files.

FDA compliance signals