 "Natco")
Natco Pharma has received approval from the Drugs Controller General of India (DCGI) to launch generic version of Gilead Sciences' hepatitis C treatment drug in India.
"The company has received approval for the generic version of ledipasvir + sofosbuvir combination from Drugs Controller General (India)", Natco Pharma said in a BSE filing today.
Natco Pharma plans to launch this combination drug immediately, under its brand name Hepcinat LP and through its strategic partners in India, it said.
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-1 CHC infection compared to conventional therapies", the company added.
Natco will price Hepcinat LP at an MRP of Rs 25,000 for a bottle of 28 tablets.
In March this year, Natco Pharma launched the generic version of sofosbuvir in Nepal.
The firm has signed a non-exclusive licensing agreement with Gilead Sciences to manufacture and sell generic versions of its chronic hepatitis C medicines.
The agreement with Gilead allows Natco to expand access to these chronic hepatitis C medicines in 91 developing countries.
Under the license, Natco can set its own price for its generic products, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities.
Natco Pharma shares were trading 0.14% up at Rs 550 per share during the morning trade on BSE.
