USV Biologics Program:
  • 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.