Strides Shasun gets DCGI nod to manufacture Sofosbuvir

Strides Shasun receives approval from Drug Controller General of India (DCGI) for generic version of Sofosbuvir

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Sofosbuvir is the first-in-class NS5B polymerase inhibitor to be launched in India for Hepatitis C

Strides Shasun has announced that it has received approval for manufacturing generic version of Sofosbuvir 400 mg (Gilead's Sovaldi) from Drug Controller General of India (DCGI).

In September 2014, Strides entered into a licensing agreement with Gilead Sciences 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 percent. Globally, it is estimated that 170-185 million people (about 3 percent of the world's population) are chronically infected with Hepatitis C virus (HCV). 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.

 

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