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    List of Drug Master Files (DMF) for 29225 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    ICATIBANT ACETATE (NON-STERILE)

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    29225
    Active
    2015-05-22
    Complete
    2015-06-30
    2015-04-24
    II
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    Looking for Drug Master Files (DMF) for 29225 of Ambiopharm Inc

    Looking for Drug Master Files (DMF) for 29225 of Ambiopharm Inc 1

    20

    Ambiopharm Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

    They are recognized for The FDA-inspected, USA-based Peptide Manufacturer with the Largest Worldwide Capacity.

    One of their notable products is ICATIBANT ACETATE (NON-STERILE), with a corresponding US DMF Number 29225.

    Remarkably, this DMF maintains an Active status since its submission on May 22, 2015, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 30, 2015, and payment made on April 24, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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