Granules India shares soar nearly 2% on receiving USFDA approval for ADHD drug

At around 1:13 pm, the stock was trading 1.21% higher at ₹590.45 per equity share.

It has advanced by over 3% in the past week and more than 8% over the month. On a year-to-date basis, it has lost more than 1%.

While the scrip touched a 52-week low of ₹422 on April 9, 2025, it reached a year’s high of ₹621.10 per equity share on January 7, 2025.

Granules Pharmaceuticals received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine extended-release orally disintegrating tablets in multiple strengths, the company said in a regulatory filing.

The company's product is the generic equivalent of Adzenys XR-ODT, it added.

The product will be manufactured at Granules' US-based facility located in Chantilly, Virginia.

The medication is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of around USD 172 million according to IQVIA (IMS Health).

Currently, the market has only one approved generic and one authorised generic, positioning Granules favourably to expand access to this critical therapy upon launch, the Hyderabad-based drug firm stated.

"The tentative approval of this ANDA reaffirms Granules' strategic focus on expanding its portfolio of complex and differentiated generics while strengthening its presence in the Central Nervous System (CNS) therapeutic area," Granules India Chairman and MD Krishna Prasad Chigurupati said.

ADHD is one of the most commonly diagnosed neurodevelopmental disorders in the US and impacts hundreds of millions of people worldwide, he added.

"This approval further strengthens Granules' US generics portfolio and underscores its continued investments in complex dosage forms, patient-friendly delivery technologies, and value-driven healthcare solutions," Chigurupati stated.

Granules India has a total market capitalisation of ₹14,328.37 crore, as of December 22, 2025, according to data on the NSE.