Overview

Biocon Biologics Limited is a subsidiary of Biocon Limited, headquartered in India. It focuses on developing and manufacturing a range of biosimilars and other biologics, serving global markets. The company is committed to providing affordable healthcare solutions through high-quality biosimilars and innovative biological drugs.

Core services & business areas

BiosimilarsRegulatory AffairsClinical DevelopmentBioprocessingCommercialization

Therapeutic areas

API / Drug Master Files

Biocon Biologics Limited holds 1 active (1 total) FDA Type II Drug Master File — 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.

  • HUMAN INSULIN-BULK (RDNA ORIGIN) (ANIMAL ORIGIN FREE)Active2010-06-07

FDA compliance signals

4 FDA enforcement records linked to this company.

  • 4832019-08-30

    Theoretical yield statement including percentages

  • 4832019-08-30

    Environmental Monitoring System

  • 4832019-08-30

    Written record of investigation incomplete

  • 4832019-08-30

    Absence of Written Procedures

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