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).

Core services & business areas

Therapeutic areas

Active pharmaceutical ingredients supplied

Substances Alkem Laboratories Limited is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

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
• LISDEXAMFETAMINE DIMESYLATEActive2023-08-03
• ESKETAMINE HYDROCHLORIDEActive2022-09-26
• SOLRIAMFETOL HYDROCHLORIDEActive2022-03-28
• CANNABIDIOLActive2022-02-08
• RITALINIC ACIDActive2021-12-21
• BIS-BOC-LISDEXAMFETAMINEActive2021-10-25

Showing 15 of 47 Drug Master Files.

FDA compliance signals