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    List of Drug Master Files (DMF) for 30429 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Amphastar Pharmaceuticals

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    AMPHASTAR NANJING PHARMACEUTICALS I...

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    PROTAMINE SULFATE USP

    PDF Supplier PDF
    URL Supplier Web Content
    30429
    Active
    2016-09-16
    Complete
    2022-10-19
    2022-10-11
    II
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    Looking for Drug Master Files (DMF) for 30429 of Amphastar Nanjing Pharmaceuticals Inc (anp) An Amphastar Co

    Looking for Drug Master Files (DMF) for 30429 of Amphastar Nanjing Pharmaceuticals Inc (anp) An Amphastar Co 1

    20

    Amphastar Nanjing Pharmaceuticals Inc (anp) An Amphastar Co, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is PROTAMINE SULFATE USP, with a corresponding US DMF Number 30429.

    Remarkably, this DMF maintains an Active status since its submission on September 16, 2016, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 19, 2022, and payment made on October 11, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II

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