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    List of Drug Master Files (DMF) for 31882 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Zhejiang Huahai Pharmaceutical

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    01 Zhejiang Huahai Pharmaceutical (1)

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    01 APREMILAST (1)

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    ZHEJIANG HUAHAI PHARMACEUTICAL CO L...

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    APREMILAST

    PDF Supplier PDF
    URL Supplier Web Content
    31882
    Active
    2017-07-12
    Complete
    2017-09-14
    2017-08-08
    II
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    Looking for Drug Master Files (DMF) for 31882 of Zhejiang Huahai Pharmaceutical Co Ltd

    Looking for Drug Master Files (DMF) for 31882 of Zhejiang Huahai Pharmaceutical Co Ltd 1

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    Zhejiang Huahai Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is APREMILAST, with a corresponding US DMF Number 31882.

    Remarkably, this DMF maintains an Active status since its submission on July 12, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 14, 2017, and payment made on August 08, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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