Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited, 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. These tablets are available in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, and are the generic equivalent of ADZENYS XR-ODT®. The manufacturing of this product will take place at Granules’ U.S.-based facility in Chantilly, Virginia. The medication is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), a condition with an estimated market size of approximately USD 172 million (₹1,430 crore) according to IQVIA. Currently, the market has only one approved generic and one authorized generic, which positions Granules favorably for market entry upon launch. Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, commented that this tentative approval aligns with Granules' strategic goal of expanding its portfolio of complex generics and strengthening its presence in the central nervous system (CNS) therapeutic area. He further emphasized the company's commitment to improving patient access to high-quality, affordable medications. This approval enhances Granules' U.S. generics portfolio, highlighting its ongoing investments in complex dosage forms and patient-friendly delivery technologies.