Biocon Biologics Limited
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.
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
Absence of Written Procedures
- 4832019-08-30
Environmental Monitoring System
- 4832019-08-30
Theoretical yield statement including percentages
- 4832019-08-30
Written record of investigation incomplete
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.