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    List of Drug Master Files (DMF) for 32303 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    ELIGLUSTAT HEMITARTRATE

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    32303
    Active
    2017-12-14
    Complete
    2018-02-02
    2017-12-13
    II
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    Looking for Drug Master Files (DMF) for 32303 of Raks Pharma Pvt Ltd

    Looking for Drug Master Files (DMF) for 32303 of Raks Pharma Pvt Ltd 1

    20

    Raks Pharma Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from WHO-GMP.

    One of their notable products is ELIGLUSTAT HEMITARTRATE, with a corresponding US DMF Number 32303.

    Remarkably, this DMF maintains an Active status since its submission on December 14, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of February 02, 2018, and payment made on December 13, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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