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    List of Drug Master Files (DMF) for 29403 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (ROUTE CODE - "ES")

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    29403
    Active
    2015-07-17
    Complete
    2015-09-09
    2015-06-17
    II
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    Looking for Drug Master Files (DMF) for 29403 of Raks Pharma Pvt Ltd

    Looking for Drug Master Files (DMF) for 29403 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 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (ROUTE CODE - "ES"), with a corresponding US DMF Number 29403.

    Remarkably, this DMF maintains an Active status since its submission on July 17, 2015, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 09, 2015, and payment made on June 17, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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