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    Raks Pharma Pvt Ltd

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-02-01

    Pay. Date : 2016-12-27

    DMF Number : 31180

    Submission : 2016-12-29

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 31180 of Raks Pharma Pvt Ltd

    Looking for Drug Master Files (DMF) for 31180 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 APREMILAST, with a corresponding US DMF Number 31180.

    Remarkably, this DMF maintains an Active status since its submission on December 29, 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