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    List of Drug Master Files (DMF) for 32211 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Alembic Pharmaceuticals Limited

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    ALEMBIC PHARMACEUTICALS LTD

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    EMPAGLIFLOZIN

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    32211
    Active
    2017-11-30
    Complete
    2017-12-22
    2017-11-24
    II
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    Looking for Drug Master Files (DMF) for 32211 of Alembic Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 32211 of Alembic Pharmaceuticals Ltd 1

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    Alembic 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 EMPAGLIFLOZIN, with a corresponding US DMF Number 32211.

    Remarkably, this DMF maintains an Active status since its submission on November 30, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 22, 2017, and payment made on November 24, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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