Granules Pharmaceuticals Inc. receives FDA tentative approval for Generic Amphetamine Extended-Release Orally Disintegrating Tablets

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 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-ODT®. 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, the Chairman and Managing Director, Dr. Krishna Prasad Chigurupati, 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.

Shares of Granules India Limited was last trading in BSE at Rs. 600.90 as compared to the previous close of Rs. 583.30. The total number of shares traded during the day was 56189 in over 1687 trades.

The stock hit an intraday high of Rs. 602.60 and intraday low of 580.70. The net turnover during the day was Rs. 33277607.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 GranulesPharmaceuticalsInc USFDA TentativeApproval