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    List of Drug Master Files (DMF) for 31182 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    RANOLAZINE

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    31182
    Active
    2016-12-28
    Complete
    2017-02-01
    2016-12-27
    II
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    Looking for Drug Master Files (DMF) for 31182 of Raks Pharma Pvt Ltd

    Looking for Drug Master Files (DMF) for 31182 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 RANOLAZINE, with a corresponding US DMF Number 31182.

    Remarkably, this DMF maintains an Active status since its submission on December 28, 2016, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of February 01, 2017, and payment made on December 27, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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