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    List of Drug Master Files (DMF) for 23300 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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    ARIPIPRAZOLE USP

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    23300
    Active
    2009-11-18
    Complete
    2013-08-28
    2013-08-19
    II
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    Looking for Drug Master Files (DMF) for 23300 of Alembic Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 23300 of Alembic Pharmaceuticals Ltd 1

    20

    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 ARIPIPRAZOLE USP, with a corresponding US DMF Number 23300.

    Remarkably, this DMF maintains an Active status since its submission on November 18, 2009, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 28, 2013, and payment made on August 19, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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