India, Hyderabad, 5 th May, 2017: Hetero, one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs, announced today that it has received the approval for the generic version of ‘Sofosbuvir+Velpatasvir’ combination from Drugs Controller General of India. The product will be marketed and distributed under the brand name ‘Velasof’ in India by Hetero Healthcare Ltd.
Sofosbuvir+Velpatasvir is a two-drug fixed dose combination product that contains 400mg of Sofosbuvir and 100mg of Velpatasvir in a single tablet. This fixed-dose combination is the generic version of Gilead’s brand Epclusa ®, approved by US FDA for the treatment of patients with chronic hepatitis C genotype 1 to 6.
This product will be launched under the non-exclusive licensing agreement with Gilead Sciences, Inc., which allows to manufacture and sell generic versions of its chronic hepatitis C medicines in 101 developing countries.