Granules India Secures USFDA Nod for ADHD Drug

Granules India has received USFDA approval for their generic ADHD medication, Amphetamine extended-release tablets. The drug, comparable to Adzenys XR-ODT, will be produced in their Virginia facility. This approval reinforces Granules' strategy in the CNS therapeutic domain and highlights their commitment to complex generic medications.

Granules India made headlines this Monday as it proudly announced receiving the US Food and Drug Administration's (USFDA) tentative approval to market a new generic drug designed for treating Attention Deficit Hyperactivity Disorder (ADHD).

This development emerges from Granules Pharmaceuticals Inc, a wholly-owned subsidiary, which has advanced its Abbreviated New Drug Application (ANDA) for Amphetamine extended-release orally disintegrating tablets. These tablets, akin to Adzenys XR-ODT, will be manufactured in the company's Virginia-based facility.

As the ADHD medication market approaches a valuation of USD 172 million, Granules' strategic positioning with limited generic competition signals potential growth. Chairman Krishna Prasad Chigurupati emphasized the significance of this approval, citing it as a reinforcement of their focus on Central Nervous System therapies and innovative pharmaceutical solutions.