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    List of Drug Master Files (DMF) for 33140 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Emcure Pharmaceuticals

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    DOLUTEGRAVIR SODIUM

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    33140
    Active
    2018-09-24
    Complete
    2019-03-01
    2019-01-30
    II
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    Looking for Drug Master Files (DMF) for 33140 of Emcure Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 33140 of Emcure Pharmaceuticals Ltd 1

    20

    Emcure Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is DOLUTEGRAVIR SODIUM, with a corresponding US DMF Number 33140.

    Remarkably, this DMF maintains an Active status since its submission on September 24, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 01, 2019, and payment made on January 30, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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