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Hyderabad-based pharmaceutical company Granules India today announced that its wholly-owned subsidiary Granules Pharmaceuticals has acquired exclusive rights from US pharma company Windlas LLC to market and distribute four products in the United States.
Windlas through its subsidiaries holds Abbreviated New Drug Applications (ANDAs) for Fingolimod, Prasugrel, Dronedarone and Lurasidone. The US firm is believed to be the first applicant to file ANDAs containing paragraph four certifications for three of these products, according to Granules.
Windlas will receive milestone payments and share of the profit from commercial sales. Granules Pharmaceuticals will be responsible for the marketing and distribution of 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. "Product in-licensing is a strategic manoeuvre to accelerate our business expansion plans in the US by fostering long-term partnerships," said Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India.
