From USFDA
Granules India announced that USFDA has approved the ANDA filed by USpharma Windlas, LLC through its subsidiaries, First Time US Generics LLC and Liberty Pharma, Inc. for Prasugrel Tablets 5 mg and 10 mg. The approved ANDA is the bioequivalent to the reference listed drug product, Effient Tablet 5mg and 10 mg of Eli Lilly and Company.Granules India through its wholly owned subsidiaries, Granules Pharmaceuticals Inc. had acquired the exclusive rights from USpharma Windlas, LLC in June 2016 to market and distribute its four products in USA, including Prasugrel.
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