Hetero, a Hyderabad-based leading generic pharmaceutical company and the world’s largest producer of anti-retroviral drugs, has received the approval from Drugs Controller General of India (DCGI) for the generic version of sofosbuvir+velpatasvir’ combination. 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.