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
163 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
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, SFDA

Drug Product :

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), SFDA, Oman and Kurdistan
Pipeline of biosimilars, at various stages of development from clinical trials to Marketing Authorization.

Biosimilars - Pegfilgrastim.

Marketing Authorization in India obtained from DCGI for Pegfilgrastim, 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 also approved in Australia, Malaysia, Switzerland, Jordan, KSA, Morocco, Qatar, Bahrain, Oman, Kurdistan, South Africa, Ukraine, Trinidad and Tobago and Israel.
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 info@usv.in

For further details please visit: www.usvbiologics.com