The approved drug is available in multiple strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.
This generic drug product has been determined to be bioequivalent (AB Rating) to the reference listed drug, Vyvanse chewable tablets by Takeda Pharmaceuticals USA Inc.
Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) in adults.
The approved drug is currently published on the FDA drug shortages list, emphasizing their critical role in patient care.
Dr Krishna Prasad Chigurupati, chairman & managing director of Granules, said, "This milestone reflects our unwavering commitment to addressing unmet patient needs by delivering high-quality, affordable medications. With this approval, GPI reinforces its dedication to alleviating critical drug shortages in the U.S. healthcare market."
Granules India now holds 68 ANDA approvals, including 30 ANDAs from GPI.
Granules India is primarily involved in the manufacturing and selling of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).
Granules India consolidated net profit fell 4.79% to Rs 97.23 crore on 18.74% decline in total revenue from operations to Rs 966.62 crore in Q2 FY25 over Q2 FY24.
The scrip rose 0.13% to currently trade at Rs 585.10 on the BSE.