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INDIA

Granules India Gains 5% on US FDA Approval for ADHD Drug

On Friday, Granules India’s shares jumped as much as 5 per cent after it received USFDA approval complex Attention Deficit Hyperactivity Disorder (ADHD) Drug.

The Indian pharmaceutical manufacturing company, Granules India was trading at Rs 362 up 0.25 per cent from its previous close, while the benchmark Sensex lost 0.09 per cent to 38806.88 points. Granules India is the world-leading APIs & Formulation 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.

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

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

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