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MUMBAI :
Shares of Granules India jumped as a lot as 5% on Friday after it obtained USFDA approval for complicated, Attention Deficit Hyperactivity Disorder (ADHD) Drug.
At 11:30 am, Granules India was buying and selling at ₹362 up 0.25% from its earlier shut, whereas the benchmark Sensex misplaced 0.09% to 38806.88 factors.
Hyderabad based mostly Granules India, a world-leading APIs & Formulations Corporation mentioned, its US subsidiary has obtained advertising and marketing approval from the US well being regulator for Dexmethylphenidate HCl extended-release capsules for the therapy of attention-deficit hyperactivity dysfunction. Granules’ capsule product is bioequivalent to the reference listed drug (RLD), Focalin XR.
“This approval from Granules Pharmaceuticals Inc, obtained inside 13 months of submitting reiterates our energy within the improvement of complicated generics. The approval of Dexmethylphenidate XR, a fancy, extended-release C-II product, is an effective addition to our portfolio. We shall be launching the product within the US market quickly,” mentioned Priyanka Chigurupati, Executive Director of Granules Pharmaceuticals.
The drug shall be manufactured on the Granules manufacturing facility in Chantilly, Virginia. The firm now has a complete of 30 ANDA approvals from the US FDA, of which 28 are ultimate approvals and a couple of are tentative.
Granules India reported a 33.87% rise in its consolidated internet revenue to ₹111.44 crore for the quarter ended June 30, 2020 in opposition to ₹83.24 crore for the corresponding interval of the earlier monetary yr. Consolidated income from operations rose 23.57% to ₹735.59 crore for the June quarter over ₹595.27 crore for the identical interval a yr in the past.
According to IQVIA Health, Dexmethylphenidate HCl ER Capsules had U.S. gross sales of roughly $556 million for twelve months ending July 2020. Focalin XR is a trademark of Novartis AG.
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