Granules India, through a subsidiary, has received U.S. Food and Drug Administration’s (FDA’s) tentative approval for its generic of attention deficit hyperactivity disorder drug Adzenys-XR-ODT.

The product, indicated for the treatment of ADHD, has an estimated market size of $172 million, the Hyderabad-based generic drugmaker said, citing IQVIA (IMS Health) numbers. It will be manufactured at Granules’ U.S.-based facility located in Chantilly, Virginia.

The market currently has only one approved generic and one authorised generic. Granules is thus positioned favourably to expand access to the critical therapy upon launch, the parent company said, announcing subsidiary Granules Pharmaceuticals Inc. receiving tentative approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Amphetamine Extended-Release orally disintegrating tablets in 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg strengths.

“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. ADHD is one of the most commonly diagnosed neurodevelopmental disorders in the U.S. and impacts hundreds of millions of people worldwide,” CMD Krishna Prasad Chigurupati said.

The approval further strengthens the U.S. generics portfolio of the company, he said in a release.

Generic drugmaker Granules India subsidiary Granules Life Sciences (GLS), located in Hyderabad, has received U.S. Food and Drug Administration (U.S. FDA) approval for a product that earlier this year was the subject of a pre-approval inspection (PAI).

The GLS facility is now deemed approved by the U.S. FDA, marking a milestone as Granules India expands its finished dosage manufacturing capabilities. This is the first FDA approval for the GLS site, the parent company said on Tuesday (November 11, 2025). There was one observation from the U.S. FDA during the inspection conducted between July 28 and August 1. The company had submitted its response within the stipulated time, it said.

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The company plans to launch the approved product in the U.S. market soon. The product is already approved and manufactured at Granules’ Gagillapur facility, near Hyderabad. The new approval will help strengthen market share and support business continuity through multi-site manufacturing, Granules said, without specifying the product.

“We plan on launching the product in the U.S. market soon. It is an already approved product at our Gagillapur facility, but we plan on building market share with this approval,” Granules India CMD Krishna Prasad Chigurupati said in a release.

There are also other products filed from the same site and expect the U.S. FDA to approve them following necessary audits if required. “The development marks the first approval from Granules’ second Hyderabad facility with finished dosage capabilities,” he said.