Granules Pharmaceuticals, Inc, a wholly owned subsidiary of Granules India Limited, has received tentative approval from the US Food and Drug Administration for its generic version of Amphetamine Extended-Release Tablets, the equivalent of DYANAVEL XR®. The approval covers strengths of 5 mg, 10 mg, 15 mg, and 20 mg. The FDA has determined that the product is eligible for 180 days of marketing exclusivity. The medication is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated US market size of approximately $41 million.
In December 2025, Granules also received tentative approval for Amphetamine Extended-Release Orally Disintegrating Tablets, the generic equivalent of ADZENYS XR-ODT®. That product currently has only one approved generic and one authorised generic, with an addressable market of about $172 million.
The latest approval represents the second tentative approval received by Granules Pharmaceuticals, Inc. within a short period, underscoring the company’s focus on complex generic formulations.
Commenting on the development, Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India Limited, said the exclusivity eligibility supports the company’s strategy of building a differentiated generics portfolio and strengthening its presence in central nervous system therapies in the US market.
Granules India Limited, founded in 1991 and headquartered in Hyderabad, is a vertically integrated pharmaceutical company with operations spanning APIs, formulation intermediates, finished dosages, and peptide manufacturing. The company operates manufacturing facilities in India, the United States, and Switzerland, and supplies products to customers in over 80 countries.
Granules India Limited is a vertically integrated pharmaceutical company with operations spanning APIs, PFIs, finished dosages, and peptide CDMO services. The company operates 11 manufacturing facilities across India, the United States, and Switzerland, and supplies products to over 300 customers in more than 80 countries. Granules holds regulatory approvals from major global agencies including the USFDA, EU GMP, EDQM, WHO, TGA, and KFDA.
