Biosimilar Drugs, Products & Medicines
We have a pipeline of 3 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
- To date investment on Biologics program is USD 80 million
- Approximately 136 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.
- 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
- 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, WHO GMP, TGA, JFDA, MHRA
Drug Product :
Biosimilars - Pegfilgrastim.
- Facility at Daman
- cGMP facility for injectables & lyophilized vials
- Pre-filled syringe facility commercialized
- Facility certified by EU GMP, MHRA, TGA, WHO - GMP, JFDA (Jordan), NHRA ( Bahrain), MOHP (UAE), MOPH (Qatar), MOH (Iraq)
- Pipeline of biosimilars, at various stages of development from clinical trials to Marketing Authorization.
- Marketing Authorization in India obtained from DCGI for Teriparatide and Human Growth Hormone, both drug substance and drug product
- Grasustek, a Pegfilgrastim biosimilar approved in EU via centralised procedure and marketed in 12 countries in EU.
- USV Pegfilgrastim is approved in Australia, Malaysia, Switzerland, Jordan and marketed in the latter 3 countries.
- USV's biologics patent portfolio consists of patents pertaining to two inventions. USV has been granted patents with respect to its pegfilgrastim process in various jurisdictions such as India, US, Europe, Brazil, Canada, Mexico and Russia.
For more information about our existing portfolio and our pipeline products please e-mail us at email@example.com
For further details please visit: www.usvbiologics.com