biosimilars market , Biosimilar drugs India

Biosimilars

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


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.

For further details please visit: www.usvbiologics.com





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