Hetero Drugs Limited

Overview

Hetero Drugs Limited is a leading Indian pharmaceutical company known for manufacturing a wide range of generic drugs, active pharmaceutical ingredients (APIs), and finished dosages. With a strong emphasis on research and development, Hetero focuses on delivering high-quality and affordable medicines to patients worldwide.

Therapeutic areas

API / Drug Master Files

Hetero Drugs Limited holds 116 active (139 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.

• ELIGLUSTAT TARTRATEActive2025-12-13
• MITAPIVAT SULFATEActive2025-10-10
• VASOPRESSIN USPActive2025-06-30
• RIFAXIMINActive2024-12-31
• ATOVAQUONE (FORM-A), PROCESS IIActive2024-12-31
• BUPROPION HYDROBROMIDEActive2024-10-18
• MICAFUNGIN SODIUMActive2024-08-16
• IRON SUCROSEActive2024-03-28
• SELENIOUS ACIDActive2024-01-25
• DESVENLAFAXINE SUCCINATEActive2023-07-01
• MIRTAZAPINEActive2023-05-15
• SOLRIAETOL HYDROCHLORIDEActive2023-04-18
• LISINOPRIL PROCESS-IIIActive2023-03-03
• RIVAROXABANActive2023-02-23
• RALTEGRAVIR POTASSIUM (FORM-III)Active2022-12-10

Showing 15 of 139 Drug Master Files.

FDA compliance signals

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