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    List of Drug Master Files (DMF) for 5809 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Delta Synthetic Co. Ltd

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    DELTA SYNTHETIC CO LTD

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    GUAIFENESIN

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    5809
    Active
    1985-04-11
    Complete
    2014-01-14
    2013-11-29
    II
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    Looking for Drug Master Files (DMF) for 5809 of Delta Synthetic Co Ltd

    Looking for Drug Master Files (DMF) for 5809 of Delta Synthetic Co Ltd 1

    20

    Delta Synthetic Co Ltd, based in Taiwan, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is GUAIFENESIN, with a corresponding US DMF Number 5809.

    Remarkably, this DMF maintains an Active status since its submission on April 11, 1985, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 14, 2014, and payment made on November 29, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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