Granules India has announced the approval of its generic equivalent to Takeda Pharmaceuticals' Vyvanse chewable tablets, a medication used for managing attention-deficit hyperactivity disorder (ADHD) and moderate to severe binge eating disorder (BED).

On December 17, Granules Pharmaceuticals Inc. (GPI), the company’s US-based subsidiary, received the green light from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets.

The approved medication is available in various strengths (10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg) and is intended for both adults and children aged six years and older. Significantly, this drug is listed on the FDA's Drug Shortages List, emphasizing its critical role in patient care.

Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, highlighted the significance of this achievement, stating, “This milestone showcases our dedication to providing high-quality and affordable medications to address unmet patient needs.”

Granules India has been strengthening its presence in the US market, notably launching a new facility in Virginia in March of last year.

Following the announcement, Granules India’s shares experienced a modest rise, trading 0.74% higher at ₹588.65 (USD $6.93) on the Bombay Stock Exchange (BSE).