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    List of Drug Master Files (DMF) for 28899 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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    TICAGRELOR

    PDF Supplier PDF
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    28899
    Active
    2015-01-09
    Complete
    2015-02-17
    2014-12-24
    II
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    Looking for Drug Master Files (DMF) for 28899 of Alembic Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 28899 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 TICAGRELOR, with a corresponding US DMF Number 28899.

    Remarkably, this DMF maintains an Active status since its submission on January 09, 2015, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of February 17, 2015, and payment made on December 24, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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