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    List of Drug Master Files (DMF) for 24754 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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    AZITHROMYCIN MONOHYDRATE USP (PROCESS-II)

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    24754
    Active
    2011-02-01
    Complete
    2014-01-06
    2013-09-26
    II
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    Looking for Drug Master Files (DMF) for 24754 of Alembic Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 24754 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 AZITHROMYCIN MONOHYDRATE USP (PROCESS-II), with a corresponding US DMF Number 24754.

    Remarkably, this DMF maintains an Active status since its submission on February 01, 2011, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 06, 2014, and payment made on September 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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