Granules Pharmaceuticals, a subsidiary of Granules India, has received tentative FDA approval for its generic Amphetamine Extended-Release Tablets (gDYANAVEL XR). The approval includes strengths of 5 mg, 10 mg, 15 mg, and 20 mg. This approval grants Granules eligibility for 180-day exclusivity, enhancing its presence in the central nervous system (CNS) therapeutic space. The estimated market size for this product is approximately USD 41 million.
FDA Tentative Approval Granted
Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited, announced on January 8, 2026, that it 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 (gDYANAVEL XR®).
Product Details and Market Opportunity
The tentative approval covers strengths of 5 mg, 10 mg, 15 mg, and 20 mg. Granules’ ANDA is eligible for 180-day exclusivity, strengthening its capabilities in developing complex generic products. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), with an estimated market size of approximately USD 41 million.
Second Consecutive Approval
This marks the second consecutive approval for Granules’ subsidiary within a few weeks, following a tentative approval on December 22nd, 2025, for Amphetamine Extended-Release Orally Disintegrating Tablets. This previous approval included strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, and targets an addressable market share of USD 172 million.
Company Statement
Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India Limited, stated, “Having a product that is eligible for 180-day exclusivity, Granules strongly validates our long-term strategy of building a differentiated portfolio of complex generics. It also reinforces our commitment to strengthening our presence in the central nervous system (CNS) therapeutic space while enhancing value creation in the U.S. generics market.”
Source: BSE
