Natco Pharma gets approval to launch combination drug of ledipasvir+sofosbuvir

From Drugs Controller General (India)

Natco Pharma announced that it has received approval for the generic version of ledipasvir+sofosbuvir combination from Drugs Controller General (India). NATCO plans to launch this combination drug immediately, under its brand name Hepcinat LP, and through its strategic partners in India.

Ledipasvir+Sofosbuvir is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet, and sold globally by Gilead Sciences, Inc., under its brand HARVONI. It is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. This single-tablet regimen is the first of its kind to offer significantly higher cure rates in Genotype-1CHC infection compared to conventional therapies.

NATCO will price its generic medicine, Hepcinat LP, at an MRP of Rs 25,000/- for a bottle of 28 tablets.

NATCO was the first licensed company to launch the generic version of this combination drug earlier in Nepal. NATCO had signed a non-exclusive licensing agreement with Gilead Sciences earlier in 2015, to manufacture and sell generic versions of its chronic hepatitis C medicines, including generic version of HARVONI, in 100 other developing countries in addition to India.

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