Granules India's USFDA Tentative Approval Adds ADHD Generic Option; Separate Form 483 Noted

said its wholly owned US subsidiary, Granules Pharmaceuticals Inc., has received tentative USFDA approval for an ANDA for Amphetamine Extended-Release Orally Disintegrating Tablets used in ADHD treatment. The product is positioned as the generic equivalent of ADZENYS XR-ODT and is planned to be manufactured at the company’s facility in Chantilly, Virginia (US). The approved strengths include 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg. Granules cited an estimated market size of about $172 million (IQVIA data for the 12 months ended November) and noted the market currently has one approved generic and one authorised generic, implying limited competition if final approval is secured and launch conditions are met. Separately, the company disclosed that one of its Hyderabad units received a USFDA Form 483 with five observations, indicating inspection findings that typically require corrective actions and follow-up. In market reaction context, the stock previously closed at ₹583.3, up 0.3% on the session, with a 17.3% gain over six months and 2.4% decline year-to-date (as reported). 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.