Granules Pharmaceuticals, Inc. wholly owned subsidiary of Granules India 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 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.
Krishna Prasad Chigurupati, chairman and managing director, Granules India said, “Product in-licensing is a strategic manoeuvre to accelerate our business expansion plans in the USA by fostering long term partnerships”.
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 (FDA).
According to IMS Health data, the annual US sales for above four products are approximately $4.4 billion.