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    List of Drug Master Files (DMF) for 32757 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    BOSENTAN MONOHYDRATE

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    32757
    Active
    2018-04-30
    Complete
    2018-05-22
    2018-04-27
    II
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    Looking for Drug Master Files (DMF) for 32757 of Raks Pharma Pvt Ltd

    Looking for Drug Master Files (DMF) for 32757 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 BOSENTAN MONOHYDRATE, with a corresponding US DMF Number 32757.

    Remarkably, this DMF maintains an Active status since its submission on April 30, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 22, 2018, and payment made on April 27, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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