Granules India subsidiary gets USFDA approval for drug used in ADHD, ED treatment

Granules India, the Hyderabad-based pharmaceutical company, has received approval from the US Food & Drug Administration (USFDA) for its Lisdexamfetamine Dimesylate chewable tablets which are used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The company said in an exchange filing dated December 17, 2024 that subsidiary the USFDA has given approval to its wholly-owned subsidiary, Granules Pharmaceuticals, Inc. (GPI), for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Chewable Tablets. The approved drug will be 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 release stated.

Granules India scrip opened in red but gained nearly 1% on Tuesday. The stock is currently trading 1.01% up at ₹590 on the NSE on December 17.

The company has received approval in the first review cycle, which reflects its focus on expedited product delivery and regulatory excellence. It now has 68 ANDA approvals from the USFDA, of which 30 ANDAs are from the company’s subsidiary GPI.

"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,” said Dr Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India.

Granules India is a manufacturer and supplier of pharmaceutical products. Products of the company include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs). These products are distributed by the company to more than 80 countries.