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    List of Drug Master Files (DMF) for 23876 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 BIOTIKA a.s. (1)

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    01 POLYMYXIN B SULFATE (1)

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    POLYMYXIN B SULFATE

    PDF Supplier PDF
    URL Supplier Web Content
    23876
    Active
    2010-05-31
    Complete
    2014-09-29
    2013-12-11
    II
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    Looking for Drug Master Files (DMF) for 23876 of Biotika As

    Looking for Drug Master Files (DMF) for 23876 of Biotika As 1

    20

    Biotika As, based in Slovakia, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is POLYMYXIN B SULFATE, with a corresponding US DMF Number 23876.

    Remarkably, this DMF maintains an Active status since its submission on May 31, 2010, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 29, 2014, and payment made on December 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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