Granules India’s wholly owned subsidiary - Granules Pharmaceuticals, Inc., (GPI) has acquired the exclusive rights from USpharma Windlas, LLC to market and distribute four products in the USA. USpharma Windlas through its subsidiaries (First time US Generics and Liberty) holds Abbreviated New Drug Applications (ANDAs) for Fingolimod, Prasugrel, Dronedarone and Lurasidone. USpharma Windlas believes to be a first applicant to file ANDAs containing paragraph IV certifications for three of these products.
USpharma Windlas will receive milestone payments and share of the profits from commercial sales. Granules Pharmaceuticals, Inc. will be responsible for the marketing and distribution of the products in the United States, subject to final approval by the US Food and Drug Administration (USFDA). According to IMS Health data, the annual US sales for above four products are approximately $4.4 billion.
Granules India produces Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) for quality conscious customers in the regulated and semi-regulated markets.
