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    List of Drug Master Files (DMF) for 18363 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 CKD Bio Corporation (1)

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    01 CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1 (1)

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    CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1

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    18363
    Active
    2005-04-14
    Complete
    2013-10-05
    2013-09-26
    II
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    Looking for Drug Master Files (DMF) for 18363 of Ckd Bio Corp

    Looking for Drug Master Files (DMF) for 18363 of Ckd Bio Corp 1

    20

    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 MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1, with a corresponding US DMF Number 18363.

    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 October 05, 2013, and payment made on September 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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