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    List of Drug Master Files (DMF) for 28464 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    TERIPARATIDE USP (ACETATE)

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    28464
    Active
    2017-06-01
    Complete
    2017-07-05
    2016-11-01
    II
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    Looking for Drug Master Files (DMF) for 28464 of Ambiopharm Inc

    Looking for Drug Master Files (DMF) for 28464 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 TERIPARATIDE USP (ACETATE), with a corresponding US DMF Number 28464.

    Remarkably, this DMF maintains an Active status since its submission on June 01, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 05, 2017, and payment made on November 01, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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