Granules Pharmaceuticals Secures USFDA Nod for Key Generic Drug

India Pharma Outlook Team | Friday, 31 January 2025

Granules India Limited, an integrated Indian pharma firm, declared that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has obtained final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) concerning Lisdexamfetamine Dimesylate Capsules available in dosages of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.

This generic medication is bioequivalent and therapeutically comparable to the reference drug, Vyvanse Capsules, in dosages of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg, manufactured by Takeda Pharmaceuticals USA, Inc. Lisdexamfetamine Dimesylate is prescribed for treating Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged six and older, along with Moderate to Severe Binge Eating Disorder (BED) in adults.

This endorsement comes after the firm's recent USFDA approval in December 2024 for Lisdexamfetamine Dimesylate Chewable Tablets, broadening Granules' extensive portfolio in the ADHD treatment area and showcasing the company's dedication to offering various treatment alternatives for patients.

With this recent authorization, Granules India Limited now possesses a total of 69 ANDA approvals, comprising 38 obtained 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."

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