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  • Granules India arm...

Granules India arm gets USFDA nod for ADHD drug Lisdexamfetamine Dimesylate

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-01-30T14:30:26+05:30  |  Updated On 30 Jan 2025 2:30 PM IST
Widely abused neurological drug formulations worth over Rs 5 crore seized in Punjab in 2024: Minister
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Hyderabad: Granules India Limited, a vertically integrated Indian pharmaceutical company, has announced that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Capsules in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.

This generic drug product is bioequivalent and therapeutically equivalent to the reference listed drug, Vyvanse Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg, of Takeda Pharmaceuticals U.S.A., Inc.
Lisdexamfetamine Dimesylate is indicated for the treatment of Attention DeficitHyperactivity Disorder (ADHD) in adults and pediatric patients aged six years and older, as well as for Moderate to Severe
Binge Eating Disorder
(BED) in adults.
This approval follows the company's recent December 2024 USFDA approval for Lisdexamfetamine Dimesylate Chewable Tablets, further expanding Granules' comprehensive portfolio in the ADHD therapeutic segment. With this latest approval, Granules India Limited now holds a total of 69 ANDA approvals, with 38 secured under the name of Granules India Limited (GIL) and 31 under Granules Pharmaceuticals, Inc. (GPI).
Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India Limited, said “With this latest approval, we are reinforcing our presence in the ADHD treatment space and strengthening our portfolio of complex generics.”

Read also: Granules India appoints Dr Rajesh Kapoor as Global Head of Quality

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.

granules indiagranules pharmaUSFDAlisdexamfetamine dimesylate capsulesvyvanse capsulestakeda pharmaattention deficit hyperactivity disorderbinge eating disorder
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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