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    List of Drug Master Files (DMF) for 31179 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    MACITENTAN

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    31179
    Active
    2016-12-13
    Complete
    2017-01-24
    2016-12-05
    II
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    Looking for Drug Master Files (DMF) for 31179 of Raks Pharma Pvt Ltd

    Looking for Drug Master Files (DMF) for 31179 of Raks Pharma Pvt Ltd 1

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    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 MACITENTAN, with a corresponding US DMF Number 31179.

    Remarkably, this DMF maintains an Active status since its submission on December 13, 2016, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2017, and payment made on December 05, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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