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    List of Drug Master Files (DMF) for 28787 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 TICAGRELOR NON-STERILE BULK DRUG SUBSTANCE (1)

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    TICAGRELOR NON-STERILE BULK DRUG SUBSTANCE

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    28787
    Active
    2015-01-30
    Complete
    2015-05-26
    2014-12-04
    II
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    Looking for Drug Master Files (DMF) for 28787 of Hec Pharm Co Ltd

    Looking for Drug Master Files (DMF) for 28787 of Hec Pharm Co Ltd 1

    20

    Hec Pharm 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 TICAGRELOR NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 28787.

    Remarkably, this DMF maintains an Active status since its submission on January 30, 2015, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 26, 2015, and payment made on December 04, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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