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.
- 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