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    List of Drug Master Files (DMF) for 27194 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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    ASENAPINE MALEATE

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    27194
    Active
    2013-07-04
    Complete
    2013-09-19
    2013-08-08
    II
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    Looking for Drug Master Files (DMF) for 27194 of Alembic Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 27194 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 ASENAPINE MALEATE, with a corresponding US DMF Number 27194.

    Remarkably, this DMF maintains an Active status since its submission on July 04, 2013, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 19, 2013, and payment made on August 08, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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