USFDA nod to Granules India arm for ADHD treatment

Granules has received approval in the first review cycle. Lisdexamfetamine Dimesylate Chewable Tablets are currently published on the FDA Drug Shortages List.

Commenting on the approval, Dr Krishna Prasad Chigurupati, Chairman & Managing Director of Granules Limited, said, "This milestone reflects our unwavering commitment to addressing unmet patient needs by delivering high-quality, affordable medications. With this approval, GPI reinforces its dedication to alleviating critical drug shortages in the U.S. healthcare market." Granules India Limited now holds 68 ANDA approvals, including 30 ANDAs from GPI.

Read also: Granules India appoints Ovais Sarmad as sustainability advisor

Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. Amongst the few pharmaceutical companies in the world to be present across the manufacturing of the entire pharmaceutical value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs), Granules products are distributed to over 300+ customers in regulated and semiregulated markets with a global presence extending to over 80+ countries with offices across India, US and UK. The Company has 10 manufacturing facilities out of which 8 are located in India and 2 are in the USA and has regulatory approvals from the US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.