Granules India Arm Gets USFDA Nod for ADHD Drug, Shares Flat Despite Exclusivity

• Granules Pharmaceuticals Inc., a US subsidiary of Granules India, received tentative USFDA approval for a generic ADHD drug.
• The approval grants 180-day exclusivity for Amphetamine Extended-Release Tablets (generic of DYANAVEL XR) in multiple strengths.
• This product has an estimated market size of approximately $41 million.
• Another tentative approval was received on Dec 22 for Amphetamine Extended-Release Orally Disintegrating Tablets (generic of ADZENYS XR-ODT) for ADHD, with a $172 million market.
• Despite the positive news, Granules India shares traded flat on Thursday, January 8, at ₹611.9, having been flat over the last 12 months.

Why It Matters: Granules India's US arm secured key USFDA approval for an ADHD drug, but its stock remained flat.