Hetero Drugs has received approval from DCGI to market generic version of Gilead’s Harvoni, a drug used in the treatment of Hepatitis C, in the India. It is the first company in India to receive the approval for the fixed-dose combination Ledipasvir-Sofosbuvir (90mg/400mg) from Drug Controller General of India (DCGI). Following the non-exclusive licensing agreement signed with Gilead Sciences in September last year, to manufacture and market chronic hepatitis C medicines, Hetero is all set to launch the fixed-dose combination therapy Ledipasvir-Sofosbuvir for Indian patients. The product will be available under the brand name ‘Ledisof’.
In India alone, it is estimated that 12-18 million patients are infected with Hepatitis C which is several fold greater than those with HIV/AIDS.
Untreated chronic hepatitis C increases the risk of cirrhosis of liver, liver failure and hepatocellular carcinoma.
Company Profile : Hetero Drugs Ltd
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