Shares of Granules India jumped as much as 5% on Friday after it received USFDA approval for complex, Attention Deficit Hyperactivity Disorder (ADHD) Drug.

At 11:30 am, Granules India was trading at 362 up 0.25% from its previous close, while the benchmark Sensex lost 0.09% to 38806.88 points.

Hyderabad based Granules India, a world-leading APIs & Formulations Corporation said, its US subsidiary has received marketing approval from the US health regulator for Dexmethylphenidate HCl extended-release capsules for the treatment of attention-deficit hyperactivity disorder. Granules’ capsule product is bioequivalent to the reference listed drug (RLD), Focalin XR.

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“This approval from Granules Pharmaceuticals Inc, received within 13 months of filing reiterates our strength in the development of complex generics. The approval of Dexmethylphenidate XR, a complex, extended-release C-II product, is a good addition to our portfolio. We will be launching the product in the US market soon," said Priyanka Chigurupati, Executive Director of Granules Pharmaceuticals.

The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia. The company now has a total of 30 ANDA approvals from the US FDA, of which 28 are final approvals and 2 are tentative.

Granules India reported a 33.87% rise in its consolidated net profit to 111.44 crore for the quarter ended June 30, 2020 against 83.24 crore for the corresponding period of the previous financial year. Consolidated revenue from operations rose 23.57% to 735.59 crore for the June quarter over 595.27 crore for the same period a year ago.

According to IQVIA Health, Dexmethylphenidate HCl ER Capsules had U.S. sales of approximately $556 million for twelve months ending July 2020. Focalin XR is a trademark of Novartis AG.