Shasun Chemicals and Drugs Ltd has signed a non-exclusive licensing agreement with Gilead Sciences Inc. for manufacture and sale of a generic version of Tenofovir Disoproxil Fumarate using Gilead's proprietary technology. Tenofovir is a well-established therapy for second line treatment of HIV/AIDS and has recently been endorsed by WHO for first-line treatment as well. It is characterized by low incidence of resistance compared to other first-line therapies.
The non-exclusive license agreement allows manufacturing both active ingredient and finished dosage, and selling product in 95 countries including India. Shasun expects to commercialise the technology received from Gilead within the next 12 months and file for regulatory approvals. Shasun already manufactures at its UK plant and commercially supplies key intermediates S-propylene carbonate and diethyl paratoluenesulfonyloxymethylphosphonate (DESMP).
Shasun offers an integrated business model by offering services in research, development and manufacturing (including Contract Research and Manufacturing Services). Shasun has the capabilities manufacturing to multi tonnes including finished dosage supplies with cGMP compliance.
Shasun has two bulk manufacturing facilities, which have been inspected successfully several times by various regulatory agencies including US FDA. Its finished dosage facility, which is recently commissioned, has been inspected by TPD Canada and MHRA, UK and expects US FDA inspection to take place by end of 2006.