Biocon Limited
Overview
Biocon Limited is an Indian biopharmaceutical company that focuses on developing affordable biosimilars and generic formulations. The company is committed to advancing healthcare by providing high-quality, innovative therapies for chronic diseases. Biocon operates across several segments, including biologics, branded formulations, and research services.
Therapeutic areas
API / Drug Master Files
Biocon Limited holds 70 active (84 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.
- TEDUGLUTIDEActive2026-03-31
- RELUGOLIXActive2026-03-30
- TRAMETINIB DIMETHYL SULFOXIDEActive2026-03-24
- EDOXABAN TOSYLATE MONOHYDRATEActive2026-01-28
- ELTROMBOPAG OLAMINEActive2025-11-30
- TIRZEPATIDEActive2025-11-24
- POSACONAZOLE (FORM-1)Active2025-10-17
- ENZALUTAMIDEActive2025-09-20
- NINTEDANIB ESYLATEActive2025-03-29
- OLAPARIBActive2025-03-26
- LINAGLIPTIN PROCESS IIActive2025-03-19
- IVACAFTORActive2025-02-28
- TICAGRELOR PH. EURActive2024-12-27
- SEMAGLUTIDEActive2024-12-21
- ROSUVASTATIN CALCIUM USP (PROCESS-III)Active2024-07-14
Showing 15 of 84 Drug Master Files.
FDA compliance signals
1 FDA enforcement record linked to this company.
- recall — Class III2016-04-20
Subpotent Drug
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