New Delhi: Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited, announced that it has received Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets, the generic equivalent of ADZENYS XR-ODT®. The approval covers six dosage strengths: 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg.
The product, indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), will be manufactured at Granules’ U.S. facility in Chantilly, Virginia. According to IQVIA (IMS Health), the ADHD market for this therapy is valued at approximately USD 172 million. With only one approved generic and one authorised generic currently available, Granules is strategically positioned to expand patient access to this critical medication upon launch.
Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India Limited, remarked: “The tentative approval of this ANDA reaffirms Granules’ strategic focus on expanding its portfolio of complex and differentiated generics while strengthening its presence in the central nervous system (CNS) therapeutic area. ADHD is one of the most commonly diagnosed neurodevelopmental disorders in the United States and impacts hundreds of millions of people worldwide. At Granules, we remain committed to improving patient access by delivering high-quality, affordable medications across global markets.”
This milestone further enhances Granules’ U.S. generics portfolio and highlights its continued investments in complex dosage forms, patient-friendly delivery technologies, and value-driven healthcare solutions.
