Granules unit gets USFDA nod for generic drug

New Delhi: Drug firm Granules India on Monday said it has received approval from the US health regulator to market a generic medication for attention deficit hyperactivity disorder.

Granules Pharmaceuticals Inc, a wholly-owned subsidiary of the company, has 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 statement.

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.

Shares of the company were trading 5.15 per cent up at Rs 588.45 apiece on BSE.