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    List of Drug Master Files (DMF) for 22157 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    CAPECITABINE

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    22157
    Active
    2008-10-27
    Complete
    2014-04-28
    2014-04-21
    II
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    Looking for Drug Master Files (DMF) for 22157 of Divi's Labotatories Ltd

    Looking for Drug Master Files (DMF) for 22157 of Divi's Labotatories Ltd 1

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    Divi's Labotatories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is CAPECITABINE, with a corresponding US DMF Number 22157.

    Remarkably, this DMF maintains an Active status since its submission on October 27, 2008, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of April 28, 2014, and payment made on April 21, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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