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. The approval covers 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®.
US-Based Manufacturing to Support Supply
Importantly, Granules will manufacture the product at its US-based facility in Chantilly, Virginia. This strengthens the company’s domestic manufacturing footprint and supports reliable supply for the US market.
Addressing a High-Need ADHD Market
As per the press release, the product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). According to IQVIA (IMS Health), the estimated market size for this therapy is approximately USD 172 million. Currently, the market includes only one approved generic and one authorized generic. As a result, Granules is well positioned to expand access to this essential treatment upon commercial launch.
Leadership Perspective on Strategic Growth
Commenting on the development, Chairman and Managing Director Dr. Krishna Prasad Chigurupati said that the tentative approval reinforces Granules’ strategic focus on building a portfolio of complex and differentiated generics. He further emphasized that the company continues to strengthen its presence in the central nervous system (CNS) therapeutic segment. Highlighting the broader impact, he noted that ADHD is among the most commonly diagnosed neurodevelopmental disorders in the United States and affects hundreds of millions of people worldwide. Accordingly, Granules remains committed to improving patient access by delivering high-quality, affordable medicines across global markets.
Strengthening the US Generics Portfolio
Overall, this milestone further enhances Granules’ US generics portfolio. Moreover, it underscores the company’s continued investments in complex dosage forms, patient-friendly delivery technologies, and value-driven healthcare solutions.