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    List of Drug Master Files (DMF) for 9716 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    CU CHEMIE UETIKON GMBH

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    4-PHENYLBUTYRIC ACID SODIUM SALT

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    Other DMF EU, CA
    9716
    Active
    1992-06-08
    Complete
    2020-12-12
    2020-12-08
    II
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    Looking for Drug Master Files (DMF) for 9716 of Cu Chemie Uetikon Gmbh

    Looking for Drug Master Files (DMF) for 9716 of Cu Chemie Uetikon Gmbh 1

    20

    Cu Chemie Uetikon Gmbh, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

    One of their notable products is 4-PHENYLBUTYRIC ACID SODIUM SALT, with a corresponding US DMF Number 9716.

    Remarkably, this DMF maintains an Active status since its submission on June 08, 1992, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 12, 2020, and payment made on December 08, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II

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