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    List of Drug Master Files (DMF) for 21963 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    DISHMAN NETHERLANDS B.V.

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    01 DISHMAN NETHERLANDS B.V. (1)

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    01 CALCIFEDIOL (1)

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    CARBOGEN AMCIS BV

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    CALCIFEDIOL

    PDF Supplier PDF
    URL Supplier Web Content
    21963
    Active
    2008-09-05
    Complete
    2016-07-28
    2016-07-08
    II
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    Looking for Drug Master Files (DMF) for 21963 of Carbogen Amcis Bv

    Looking for Drug Master Files (DMF) for 21963 of Carbogen Amcis Bv 1

    20

    Carbogen Amcis Bv, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is CALCIFEDIOL, with a corresponding US DMF Number 21963.

    Remarkably, this DMF maintains an Active status since its submission on September 05, 2008, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 28, 2016, and payment made on July 08, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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