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    List of Drug Master Files (DMF) for 25531 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Chengdu Shengnuo Biopharm

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    01 Chengdu Shengnuo Biopharm (1)

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    01 BIVALIRUDIN (NON-STERILE BULK DRUG) (1)

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    CHENGDU SHENGNUO BIOPHARM CO LTD

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    BIVALIRUDIN (NON-STERILE BULK DRUG)

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    25531
    Active
    2012-05-14
    Complete
    2013-12-18
    2013-08-13
    II
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    Looking for Drug Master Files (DMF) for 25531 of Chengdu Shengnuo Biopharm Co Ltd

    Looking for Drug Master Files (DMF) for 25531 of Chengdu Shengnuo Biopharm Co Ltd 1

    20

    Chengdu Shengnuo Biopharm Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is BIVALIRUDIN (NON-STERILE BULK DRUG), with a corresponding US DMF Number 25531.

    Remarkably, this DMF maintains an Active status since its submission on May 14, 2012, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 18, 2013, and payment made on August 13, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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