Granules Pharmaceuticals Inc has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) 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-OD. It will be manufactured at Granules’ US-based facility located in Chantilly, Virginia.

The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of approximately USD 172 million, according to IQVIA (IMS Health).

Currently, the market has only one approved generic and one authorised generic, positioning Granules favourably to expand access to this critical therapy upon launch.

Commenting on the development, Dr Krishna Prasad Chigurupati, Chairman and Managing Director, stated, “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 approval further strengthens Granules’ US generics portfolio and underscores its continued investments in complex dosage forms, patient-friendly delivery technologies and value-driven healthcare solutions.