Granules Pharmaceuticals Inc., a subsidiary of Granules India, has received tentative FDA approval for its generic Amphetamine Extended-Release Orally Disintegrating Tablets (ADZENYS XR-ODT®). Indicated for ADHD treatment, the product addresses a market estimated at USD 172 million. The medication will be produced at their US-based facility, enhancing Granules’ central nervous system (CNS) portfolio.
FDA Approval for ADHD Treatment
Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited, has achieved tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) concerning Amphetamine Extended-Release Orally Disintegrating Tablets. The generic equivalent of ADZENYS XR-ODT® will be available in strengths including 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg.
Manufacturing and Market Positioning
The manufacturing of these tablets will take place at Granules’ US-based facility located in Chantilly, Virginia. This strategic approval allows Granules to tap into a market for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), which is currently valued at approximately USD 172 million, according to IQVIA (IMS Health).
Strategic Impact
According to Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, this tentative approval reaffirms Granules’ focus on expanding its portfolio of complex generics. By addressing a commonly diagnosed neurodevelopmental disorder, Granules remains committed to delivering affordable medications. This initiative strengthens Granules’ US generics portfolio, contributing to patient-friendly healthcare solutions. The approval was announced on December 22, 2025.
Source: BSE
