Granules Pharmaceuticals receives FDA tentative approval for gDYANAVEL XR

Granules Pharmaceuticals, a wholly owned subsidiary of Granules India, has received tentative approval (TA) from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Amphetamine Extended-Release (gDYANAVEL XR) tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg, the generic equivalent of DYANAVEL XR.

The Granules ANDA has been determined to be eligible for 180-day exclusivity by the FDA, reinforcing its growing capabilities in developing and commercializing complex and differentiated generic products for the US market. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of approximately USD 41 million.

Granules previously received a tentative approval on December 22nd, 2025 for Amphetamine Extended- Release Orally Disintegrating Tablets in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, the generic equivalent of ADZENYS XR-ODT also for the treatment of ADHD. This product has only one approved generic and one authorized generic with an addressable market share of USD 172 million, positioning Granules favourably to expand access to this critical therapy upon launch. The tentative approval of generic gDYANAVEL XR tablets marks the second consecutive approval from Granules’ subsidiary, Granules Pharmaceuticals, Inc., within a period of a few weeks.

Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India Limited, said, “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.”

This achievement highlights Granules’ expanding capabilities in complex formulation development and regulatory execution. It reinforces the Company’s ability to identify, develop, and progress technically challenging products that deliver meaningful differentiation and long-term value.

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