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    List of Drug Master Files (DMF) for 33122 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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    BREXPIPRAZOLE

    PDF Supplier PDF
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    33122
    Active
    2018-09-29
    Complete
    2019-06-07
    2019-04-15
    II
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    Looking for Drug Master Files (DMF) for 33122 of Alembic Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 33122 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 BREXPIPRAZOLE, with a corresponding US DMF Number 33122.

    Remarkably, this DMF maintains an Active status since its submission on September 29, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 07, 2019, and payment made on April 15, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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