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    List of Drug Master Files (DMF) for 30964 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Aurobindo Pharma Limited

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    APITORIA PHARMA PRIVATE LTD

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    CANAGLIFLOZIN

    PDF Supplier PDF
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    30964
    Active
    2016-09-28
    Complete
    2016-12-09
    2016-09-23
    II
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    Looking for Drug Master Files (DMF) for 30964 of Apitoria Pharma Private Ltd

    Looking for Drug Master Files (DMF) for 30964 of Apitoria Pharma Private Ltd 1

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    Apitoria Pharma Private 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 CANAGLIFLOZIN, with a corresponding US DMF Number 30964.

    Remarkably, this DMF maintains an Active status since its submission on September 28, 2016, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 09, 2016, and payment made on September 23, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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