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Strides Shasun receives approval from DCGI for generic version of Sofosbuvir

21 Dec 2015 Evaluate

Strides Shasun has received approval for manufacturing generic version of Sofosbuvir 400 mg (Gilead’s Sovaldi) from Drug Controller General of India, Government of India (DCGI). In September 2014, Strides entered into a licensing agreement with Gilead Sciences, Inc to bring Hepatitis C cure to 91 developing countries. The product will continue to be marketed under the brand name ‘Virso’ in India and overseas.

Sofosbuvir is the first-in-class NS5B polymerase inhibitor to be launched in India for Hepatitis C treatment and represents a paradigm shift in the existing Hepatitis C cure. The high potency, high barrier to resistance, pan genotypic activity, once-daily dosage, good safety profile and the limited drug-drug interactions of Sofosbuvir makes it a breakthrough drug in Hepatitis C treatment. This drug in combination therapy has shown to have high cure rates of around 90%.

Strides Shasun is a vertically integrated global pharmaceutical company headquartered in Bangalore. The company has four business verticals - Regulated Markets, Emerging Markets, Institutional Business and Pharmaceutical Services & Active Ingredients.



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