Mumbai, Dec. 22 -- The said product is a generic equivalent of ADZENYS XR-ODT, will be manufactured at Granules' US facility in Chantilly, Virginia. It will be available in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). According to IQVIA (IMS Health), the drug has an estimated market size of approximately $172 million.

Currently, the market has only one approved generic and one authorised generic, giving Granules a favourable position to expand access to this therapy upon launch.

The company said the tentative approval strengthens its US generics portfolio and underscores its continued investments in complex dosage forms, patient-...