Granules India Limited — Updates, 30-01-2025: Press Release

Granules India Limited has strengthened its portfolio in the ADHD therapeutic segment by receiving final approval from the U.S. FDA for its Lisdexamfetamine Dimesylate Capsules, available in multiple strengths (10 mg to 70 mg). This generic product is bioequivalent to Takeda Pharmaceuticals' Vyvanse® and is indicated for treating Attention Deficit Hyperactivity Disorder (ADHD) and Moderate to Severe Binge Eating Disorder (BED) in adults and children over six years. This approval, following the recent FDA approval for Lisdexamfetamine Dimesylate Chewable Tablets, brings Granules' total ANDA approvals to 69, enhancing its complex generics offerings. Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, emphasized the significance of this approval in reinforcing their presence in the ADHD market, suggesting a positive outlook for future growth in this sector.