Hetero Labs Limited

Overview

Hetero Labs Limited is a leading global pharmaceutical company based in India, specializing in the development, manufacturing, and distribution of generic pharmaceuticals. It is known for its expertise in antiretroviral drugs and a strong presence in both the domestic and international markets.

Therapeutic areas

API / Drug Master Files

Hetero Labs Limited holds 150 active (163 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.

• AXITINIB (FORM-XLI)Active2025-11-05
• LENACAPAVIR SODIUMActive2025-10-27
• LENACAPAVIR SPRAY-DRIED DISPERSIONActive2025-10-27
• VISMODEGIBActive2025-08-20
• ASCIMINIB HYDROCHLORIDE PREMIXActive2025-07-29
• ASCIMINIB HYDROCHLORIDE PREMIXActive2025-07-29
• AVACOPANActive2025-06-26
• ABEMACICLIBActive2025-05-22
• BELZUTIFAN PREMIXActive2025-05-20
• BELUMOSUDIL MESYLATEActive2025-04-29
• IVACAFTOR PREMIXActive2025-03-27
• OPICAPONEActive2025-03-27
• DASATINIB MONOHYDRATEActive2025-03-27
• CRIZOTINIBActive2025-03-25
• SOTORASIB (FORM-III)Active2025-03-03

Showing 15 of 163 Drug Master Files.

FDA compliance signals

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