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    List of Drug Master Files (DMF) for 32005 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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    DAPAGLIFLOZIN

    PDF Supplier PDF
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    32005
    Active
    2017-08-31
    Complete
    2018-01-04
    2017-08-22
    II
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    Looking for Drug Master Files (DMF) for 32005 of Alembic Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 32005 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 DAPAGLIFLOZIN, with a corresponding US DMF Number 32005.

    Remarkably, this DMF maintains an Active status since its submission on August 31, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 04, 2018, and payment made on August 22, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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