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    Sun Pharma gets USFDA nod for generic drug Mesalamine extended release capsules

    Synopsis

    The company has received approval from the US Food and Drug Administration (USFDA) for the product, a generic version of Pentasa extended release capsules (500 mg), the Mumbai-based drug major said in a statement. As per March 2022 IQVIA Health data, Pentasa had annualised sales of around USD 213 million in the US market.

    USFDA issues 3 minor observations to Granules India arm in pre-approval inspectionAP
    US Food and Drug Administration (USFDA)
    Sun Pharmaceutical Industries on Thursday said it has received final approval from the US health regulator for Mesalamine extended release capsules, used to treat bowel disease, in the American market.

    The company has received approval from the US Food and Drug Administration (USFDA) for the product, a generic version of Pentasa extended release capsules (500 mg), the Mumbai-based drug major said in a statement.

    As per March 2022 IQVIA Health data, Pentasa had annualised sales of around USD 213 million in the US market.


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