Zydus receives US FDA approval for anti-viral drug oseltamivir

The group has also received the US drug regulator's nod to market anti-bacterial drug, linezolid

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BS B2B Bureau Ahmedabad

Last Updated : Feb 27 2017 | 3:20 PM IST

Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA, has received final approval from the US Food & Drug Administration (FDA) to market oseltamivir phosphate capsule in strengths of 30 mg, 45 mg and 75 mg. The drug, an anti-viral used in the prevention and treatment of influenza virus infection, will be produced at the Nesher Pharmaceuticals manufacturing facility located in St. Louis (Missouri, USA).

As per IMS December 2016 (MAT), the estimated sales for oseltamivir phosphate capsule is $382 million.

The group has also received the final approval from the USFDA to market linezolid tablet (600 mg). The drug is an anti-bacterial agent used to treat certain serious bacterial infections and will be produced at the group’s formulations manufacturing facility at the pharma SEZ in Ahmedabad.

The group now has nearly 110 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.