Granules India: USFDA Tentative Approvals Strengthen ADHD Generic Pipeline

said its wholly owned US subsidiary, Granules Pharmaceuticals Inc., has received USFDA tentative approval for its abbreviated new drug application (ANDA) for generic Amphetamine Extended-Release Tablets in 5 mg, 10 mg, 15 mg, and 20 mg strengths, positioned as the generic equivalent of DYANAVEL XR. The company estimated the market size for this product at about $41 million. Separately, Granules noted it had earlier (December 22) received tentative approval for Amphetamine Extended-Release Orally Disintegrating Tablets across six strengths—3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, aligned to ADZENYS XR-ODT for ADHD. For this segment, Granules highlighted a more limited competitive set (one approved generic and one authorised generic) with an addressable market share of $172 million, which could support differentiated entry once final approval enables launch. Management also emphasized eligibility for 180-day exclusivity for one product, framing it as validation of the company’s strategy to build a differentiated complex-generics portfolio. Granules India shares were cited at about ₹611.9, with the stock described as flat over the past 12 months. Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.