USFDA nod to Granules India arm for ADHD treatment
Hyderabad: Granules India Limited, a vertically integrated Indian pharmaceutical company, announced today that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Chewable Tablets.
The approved drug is available in multiple strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.
This generic drug product has been determined to be bioequivalent (AB Rating) to the reference listed drug, Vyvanse Chewable Tablets by Takeda Pharmaceuticals USA Inc.
Lisdexamfetamine Dimesylate chewable tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged six years and older, as well as Moderate to Severe Binge Eating Disorder (BED) in adults.
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.
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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.
