Granules Pharmaceuticals, Inc (GPI), a wholly owned subsidiary of Granules India, has acquired exclusive rights from USpharma Windlas, LLC to market and distribute four products in the US.

USpharma Windlas through its subsidiaries 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.

As part of the agreement, USpharma Windlas will receive milestone payments and share of the profits from commercial sales.

GPI will be responsible for the marketing and distribution of the products in the US, subject to final approval by the US Food and Drug Administration (US FDA). According to the IMS Health data, the annual US sales for the above four products are approximately $4.4 billion.

“Product in-licensing is a strategic manoeuvre to accelerate our business expansion plans in the US by fostering long term partnerships,” Krishna Prasad Chigurupati, Chairman and MD, Granules India, said in a release issued here on Thursday.

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