Granules India Subsidiary Gains FDA Tentative Approval for ADHD Drug
Filing Summary
Granules Pharmaceuticals, Inc., a subsidiary of Granules India Limited, has received tentative approval from the U.S. FDA for its generic Amphetamine Extended-Release Tablets, equivalent to DYANAVEL XR®. The approval includes a 180-day exclusivity period. The product, used for treating ADHD, targets a market valued at approximately USD 41 million. This follows a previous tentative approval for another ADHD treatment, ADZENYS XR-ODT®. Granules India continues to expand its presence in the U.S. generics market, focusing on complex formulations and regulatory execution.
Granules Pharmaceuticals, Inc., a wholly owned subsidiary of Granules India Limited, has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Amphetamine Extended-Release Tablets. These tablets are the generic equivalent of DYANAVEL XR® and are available in strengths of 5 mg, 10 mg, 15 mg, and 20 mg. The FDA has granted a 180-day exclusivity period for this product, which is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The estimated market size for the generic Amphetamine Extended-Release Tablets is approximately USD 41 million. This approval marks a significant step for Granules Pharmaceuticals in the U.S. market, reinforcing its capabilities in developing and commercializing complex generic products. The exclusivity period allows Granules to market the product without competition from other generic manufacturers for 180 days.
Granules Pharmaceuticals had previously received tentative approval on December 22, 2025, for Amphetamine Extended-Release Orally Disintegrating Tablets, the generic equivalent of ADZENYS XR-ODT®. This product is also used for treating ADHD and has an addressable market share of USD 172 million. The approval of these products highlights Granules’ focus on expanding its portfolio in the central nervous system (CNS) therapeutic space.
The tentative approval for the generic gDYANAVEL XR tablets is the second consecutive approval for Granules Pharmaceuticals within a few weeks. This development underscores the company’s ability to identify and develop technically challenging products that offer meaningful differentiation in the market. The approval process reflects Granules’ commitment to regulatory execution and complex formulation development.
Granules Pharmaceuticals, Inc. is actively involved in the U.S. generics market, focusing on the development of complex and differentiated generic products. The company’s strategy includes building a portfolio that enhances its presence in the CNS therapeutic area, aiming to provide critical therapies to the market upon product launch.
Granules India Limited, incorporated in 1991, is a vertically integrated pharmaceutical company headquartered in Hyderabad, India. The company is involved in the manufacturing of the entire pharmaceutical value chain, including Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs). Granules India distributes its products to over 300 customers in regulated and semi-regulated markets, with a global presence in more than 80 countries. The company operates 11 manufacturing facilities, with regulatory approvals from various international agencies.