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
Active pharmaceutical ingredients supplied
Substances Biocon 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
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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