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    Granules India gets USFDA nod for allergy treatment drug Loratadine

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-12-25T09:50:50+05:30  |  Updated On 25 Dec 2019 9:50 AM IST

    "The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules India Ltd, for Loratadine tablets USP, 10 mg (OTC)," Granules India said in a filing to BSE.


    New Delhi: Granules India on Tuesday said the US health regulator has given its approval to the abbreviated new drug application filed by the drug firm for Loratadine tablets used to treat allergies.


    "The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules India Ltd, for Loratadine tablets USP, 10 mg (OTC)," Granules India said in a filing to BSE.


    The approved ANDA is bioequivalent to the Reference Listed Drug (RLD), Claritin tablets 10 mg by Bayer HealthCare LLC, the filing said.


    Read Also: Granules India gets USFDA nod for Fexofenadine Hydrochloride tablets to treat allergy symptoms


    The company further said that it intends to commercialise this product "shortly".


    Granules India was formed in 1984 as Triton Laboratories. Triton produced Paracetamol API at its Bonthapally factory on the outskirts of Hyderabad. The company manufactures several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and semi-regulated markets.


    Read Also: Granules India to exit from Chinese JV Granules Biocause

    Abbreviated New Drug Applicationallergiesbayer healthcareClaritinGranules IndiaLoratadineloratadine tabletspharmapharma companypharma newsUSFDA
    Source : PTI

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    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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