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    List of Drug Master Files (DMF) for 25427 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    CELECOXIB USP

    PDF Supplier PDF
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    25427
    Active
    2012-01-03
    Complete
    2017-03-02
    2016-08-19
    II
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    Looking for Drug Master Files (DMF) for 25427 of Amoli Organics Pvt Ltd

    Looking for Drug Master Files (DMF) for 25427 of Amoli Organics Pvt Ltd 1

    20

    Amoli Organics Pvt 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 CELECOXIB USP, with a corresponding US DMF Number 25427.

    Remarkably, this DMF maintains an Active status since its submission on January 03, 2012, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 02, 2017, and payment made on August 19, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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