Granules India Dexmethylphenidate HCl ER capsules get USFDA approval to treat ADHD
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
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.