Granules acquires rights for 4 products from USpharma

Hyderabad: Pharmaceuticals manufacturing company Granules India Limited on Thursday said that its fully-owned subsidiary, Granules Pharmaceuticals Inc, has entered into an agreement to acquire the exclusive rights from USpharma Windlas LLC to market and distribute four products in the US.

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.

According to a company statement, USpharma Windlas will receive milestone payments and share of the profits from commercial sales. Granules Pharmaceuticals 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 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,” said Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India.