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    List of Drug Master Files (DMF) for 30084 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    DEXLANSOPRAZOLE (ROUTE CODE - DR)

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    30084
    Active
    2016-05-13
    Complete
    2016-07-06
    2016-05-06
    II
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    Looking for Drug Master Files (DMF) for 30084 of Raks Pharma Pvt Ltd

    Looking for Drug Master Files (DMF) for 30084 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 DEXLANSOPRAZOLE (ROUTE CODE - DR), with a corresponding US DMF Number 30084.

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

    Their GDUFA DMF Review was successfully complete, with a review date of July 06, 2016, and payment made on May 06, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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