Granules India has entered into an agreement with USpharma Windlas Llc, a joint venture between USpharma Ltd and Windlas Healthcare Pvt Ltd, to market and distribute four products in the US. “Product in-licensing is a strategic manoeuvre to accelerate our business expansion plans in the US by fostering long-term partnerships,” commented Krishna Prasad Chigurupati, chairman and managing director, Granules India.
Through its subsidiaries, USpharma Windlas holds abbreviated new drug applications (ANDAs) for fingolimod, prasugrel, dronedarone and lurasidone, and the company claims to be a first applicant to file ANDAs containing Para IV certifications for three of these products. As per IMS Health data, the annual US sales for these four products are approximately $ 4.4 billion.
USpharma Windlas will receive milestone payments and share of the profit from commercial sales. Granules Pharmaceuticals Inc, the wholly-owned subsidiary of Granules India, will be responsible for the marketing and distribution of products in the US, subject to final approval by the US Food and Drug Administration (USFDA).

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