Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received final approval from the US FDA to market oseltamivir phosphate capsules, USP in strengths of 30mg, 45mg and 75mg. The drug will be produced at the Nesher Pharmaceuticals USA manufacturing facility located in St. Louis, Missouri, USA. It is an anti-viral used in the prevention and treatment of influenza virus infection. The estimated sales for oseltamivir phosphate capsules is $382 mn as per IMS December 2016 (MAT).
The group has also received the final approval from the US FDA to market Linezolid tablets USP, 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.