Granules India Dexmethylphenidate HCl ER capsules get USFDA approval to treat ADHD
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Hyderabad: Drugmaker Granules India has recently announced that the company's US subsidiary has received marketing approval from the U.S. Health Regulator (FDA) 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.
Sharing the exciting news, Priyanka Chigurupati, Executive Director of Granules Pharmaceuticals Inc. said "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."
The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia.
Granules now have a total of 30 ANDA approvals from the US FDA (28 Final approvals and 2 tentative approvals).
According to IQVIA Health,Dexmethylphenidate HCl ER Capsules had U.S. sales of approximately $556 million*for the most recent twelve months ending in July 2020.
Focalin XR is a trademark of Novartis AG.
Granules India is an Indian pharmaceutical manufacturing company that was founded in 1984 named as Triton Laboratories located in Hyderabad, India.
Granules manufactures varieties of drugs including Paracetamol, Ibuprofen, Metformin, and Guaifenesin, on a large scale for customers in the domestic as well as international markets.
Read also: Granules India net profit up 34 percent to Rs 111.4 crore in Q1
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