Granules India Limited, established in 1991 and headquartered in Hyderabad, Telangana, is a vertically integrated pharmaceutical company specialising in the development, manufacturing, and distribution of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs).
Granules India Ltd, announced on January 30, 2025, that its subsidiary has received final approval from the United States Food and Drug Administration (USFDA) for its generic version of Lisdexamfetamine Dimesylate capsules. This medication is prescribed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The approval granted to Granules Pharmaceuticals, Inc. covers the Abbreviated New Drug Application (ANDA) for capsules in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. The company confirmed that its product is both bioequivalent and therapeutically equivalent to Vyvanse capsules, developed by Takeda Pharmaceuticals USA, Inc., in the same strengths.
Lisdexamfetamine Dimesylate is indicated for managing ADHD in adults and children aged six years and above, as well as for treating moderate to severe Binge Eating Disorder (BED) in adults. Commenting on this milestone, Granules India’s Chairman and Managing Director, Krishna Prasad Chigurupati, said:
“This latest approval reinforces our stronghold in the ADHD therapeutic segment while expanding our portfolio of complex generics. It underscores our commitment to delivering affordable, high-quality treatments that cater to critical patient needs.”
Granules India reported a 6% year-on-year decline in consolidated net profit, which stood at ₹118 crore for the quarter ending December 31, 2024, compared to ₹126 crore in the same period the previous year. Revenue from operations marginally slipped to ₹1,138 crore from ₹1,156 crore in the corresponding period last year.
However, the company demonstrated resilience, with North American operations contributing 77% to total revenue—an impressive increase from 66% in the previous year. Finished dosages constituted 76% of total revenue, while Active Pharmaceutical Ingredients (APIs) and pharmaceutical formulation intermediates contributed 12% each.
At 9:25 AM on January 31, 2025, Granules India Ltd shares traded at ₹560.40 per share on the NSE.
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Published on: Jan 31, 2025, 2:40 PM IST
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