Pharma firm Granules India today said its subsidiary has entered into a product in-licensing pact with US pharma Windlas, LLC to market and distribute four products in the US.
US pharma Windlas will receive milestone payments and the share of profits from commercial sales.
In a BSE filing, Granules India said: “Its wholly-owned subsidiary Granules Pharmaceuticals, Inc.,(GPI) has acquired the exclusive rights from USpharma Windlas, LLC to market and distribute four products in the USA”.
US pharma Windlas LLC is a joint venture between USpharma Ltd and Windlas Healthcare Pvt Ltd.
It added: “US pharma Windlas through its subsidiaries holds Abbreviated New Drug Application (ANDA) 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.”
Granules said it will be responsible for the marketing and distribution of the products in the US, subject to the final approval by the US Food and Drug Administrations (USFDA).
“Product in-licensing is a strategic monuvere to accelerate our manoveuvre expansion plans in the USA by fostering long term partnerships,” Granules India CMD Krishna Prasad Chigurupati said.
Quoting IMS data, Granules said the four product had annual sales of USD 4.4 billion.