USV Private Limited

Biosimilars

Biosimilars

Biosimilar Drugs, Products & Medicines

We have a pipeline of 7 biosimilar (products produced by recombinant biotechnology in E.coli) at various stages of development, from lab scale, clinical to market authorisation.

• An initiative which came into being in 1998
• Investment of USD 73 million in Biologics program to date
• Approximately 110 employees involved in research, development and manufacturing
• Biologics facilities located across three sites of USV:
• Research & Development
• Located in Mumbai, India
• Research groups include molecular biology, fermentation, downstream processing, analytical development, bioassay / immunoassay and dosage development.
• Manufacturing
• The Drug Substance & Drug Product manufacturing facilities are built as per cGMP, EU & USFDA regulatory requirements.
• Drug substance
• Facility at Nerul, Navi Mumbai spread over 3800 sq. m
• Fully functional State-of-the-art GMP facility
• Capacity expansion to Commercial scale completed
• State-of-the-Art QC with complete in-house product release
• Designed for continous operation with redundancy created in the utilities to take care of breakdown and maintenance
• Facility certified by EU GMP and WHO GMP
• Drug Product
• Facility at Daman
• cGMP facility for injectables & lyophilized vials
• Pre-filled syringe facility installation and validation completed
• Facility certified by WHO GMP, MHRA, USFDA and Canadian Health Authority
• Pipeline of biosimilars, at various stages of development from clinical trials to Marketing Authorization.
• Biosimilars - Pegfilgrastim, Teriparatide, Somatropin.
• Marketing Authorization in India obtained from DCGI for Teriparatide and Human Growth Hormone, both drug substance and drug product
• Grasustek, a Pegfilfigrastim biosimilar approved in EU via centralised procedure
• A total of 10 patent submissions for inventions, 6 of which have been granted.