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    List of Drug Master Files (DMF) for 18362 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    CKD Bio Corporation

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    01 CLAVULANATE POTASSIUM WITH SILICON DIOXIDE IN THE RATIO 1:1, NON-STERILE BULK DRUG SUBSTANCE (1)

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    CLAVULANATE POTASSIUM WITH SILICON DIOXIDE IN THE RATIO 1:1, NON-STERILE BULK DRUG SUBSTANCE

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    18362
    Active
    2005-04-14
    Complete
    2013-07-02
    2013-06-11
    II
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    Looking for Drug Master Files (DMF) for 18362 of Ckd Bio Corp

    Looking for Drug Master Files (DMF) for 18362 of Ckd Bio Corp 1

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    Ckd Bio Corp, based in South Korea, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is CLAVULANATE POTASSIUM WITH SILICON DIOXIDE IN THE RATIO 1:1, NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 18362.

    Remarkably, this DMF maintains an Active status since its submission on April 14, 2005, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 02, 2013, and payment made on June 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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