Granules India gets USFDA approval for capsules to treat ADHD

Granules India Limited’s US subsidiary has received marketing approval from United States Food & Drug Administration (USFDA) for Dexmethylphenidate HCL extended-release capsules for the treatment of attention-deficit/hyperactivity disorder (ADHD).

ADHD is a disorder that makes it difficult for a person to pay attention and control impulsive behaviours. It is usually first diagnosed in childhood and often lasts into adulthood. One may also be restless and almost constantly active.

Granules’ capsule product is bioequivalent to the reference listed drug (RLD), Focalin XR, which is a trademark of Novartis AG.

The drug will be manufactured at Granules manufacturing facility in Chantilly (Virginia). The company’s management informed that it has received this approval within 13 months of filing it. This addition will further strengthen its product portfolio as the company is keen to launch this product soon in the US market.

As per the data provided by IQVIA Health in July 2020, Dexmethylphenidate HCL ER Capsules had US sales of approximately USD 556 million for the most recent twelve-month ending in July 2020.

With this, Granules now has a total of 30 ANDA approvals from USFDA of which, 28 are final approvals and 2 are tentative approvals.

On Friday, the stock of Granules opened a gap up 4.7 per cent at Rs 378 from its previous close of Rs 361.10 on BSE.