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    Granules India gets USFDA nod for Methylphenidate Hydrochloride ER capsules

    Farhat NasimWritten by Farhat Nasim Published On 2019-05-28T10:00:43+05:30  |  Updated On 16 Aug 2021 4:47 PM IST

    The approved product, Methylphenidate Hydrochloride extended-release capsules, is bioequivalent to the reference listed drug product (RLD), Ritalin LA extended-release capsules of Novartis Pharmaceuticals Corporation.


    New Delhi: Drug firm Granules India Monday said its subsidiary has received approval from the US health regulator for Methylphenidate Hydrochloride extended-release capsules, used for the treatment of attention deficit hyperactivity disorder (ADHD).


    The approved product is bioequivalent to the reference listed drug product (RLD), Ritalin LA extended-release capsules of Novartis Pharmaceuticals Corporation.


    Read Also: Granules India gets USFDA nod for Acetaminophen extended release tablets


    The US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, a wholly-owned foreign subsidiary of Granules India, for Methylphenidate Hydrochloride extended-release capsules in the strengths of 10 mg, 20 mg, 30 mg, 40 mg and 60 mg, Granules said in a BSE filing.


    Granules India said, till date, Granules Pharmaceuticals had submitted a total 19 ANDAs and the current approval is the third ANDA approval for the entity. Go-ahead for the balance 16 ANDAs are awaited.


    The company is based in Hyderabad and manufactures tablets, Pharmaceutical Formulation Intermediates (PFIs) and active pharmaceutical ingredients (APIs) which are distributed in over 74+ countries.


    Granules manufacture several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and semi-regulated markets.


    Also Read: Granules India Q1 net profit up 41 per cent to Rs 51.7 crore

    Abbreviated New Drug ApplicationADHD treatment drugANDAattention deficit hyperactivity disorderBSEGranulesGranules PharmaceuticalsGuaifenesinibuprofenIndiaMetforminMethylphenidateMethylphenidate HydrochlorideNew DelhiNovartisNovartis Pharmaceuticals CorporationParacetamolShares of GranulestreatmentUS Food and Drug AdministrationUS healthUSFDA
    Source : With inputs

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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