Granules India Limited has announced that its wholly-owned subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received USFDA approval for its Lisdexamfetamine Dimesylate Chewable Tablets. The approved strengths include 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg, bioequivalent to Vyvanse® Chewable Tablets by Takeda Pharmaceuticals USA Inc.
The tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged six years and older, and Moderate to Severe Binge Eating Disorder (BED) in adults.
Granules secured the approval in the first review cycle, reflecting its focus on regulatory excellence. The drug is listed on the FDA Drug Shortages List, addressing a critical supply gap in the U.S. market.
Dr. Krishna Prasad Chigurupati, Chairman & MD of Granules India, stated, “This milestone reflects our unwavering commitment to addressing unmet patient needs by delivering high-quality, affordable medications.”
With this approval, Granules India now holds 68 ANDA approvals, including 30 from GPI, further strengthening its position in the U.S. pharmaceutical market.