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.

Core services & business areas

Therapeutic areas

Active pharmaceutical ingredients supplied

Substances Hetero Labs 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

Hetero Labs Limited holds 151 active (164 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.

• OLAPARIB (FORM-A)Active2026-04-22
• AXITINIB (FORM-XLI)Active2025-11-05
• LENACAPAVIR SODIUMActive2025-10-27
• LENACAPAVIR SPRAY-DRIED DISPERSIONActive2025-10-27
• VISMODEGIBActive2025-08-20
• ASCIMINIB HYDROCHLORIDE PREMIXActive2025-07-29
• AVACOPANActive2025-06-26
• ABEMACICLIBActive2025-05-22
• BELZUTIFAN PREMIXActive2025-05-20
• BELUMOSUDIL MESYLATEActive2025-04-29
• DASATINIB MONOHYDRATEActive2025-03-27
• OPICAPONEActive2025-03-27
• IVACAFTOR PREMIXActive2025-03-27
• CRIZOTINIBActive2025-03-25
• SOTORASIB (FORM-III)Active2025-03-03

Showing 15 of 164 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.