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    List of Drug Master Files (DMF) for 25099 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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    BOSENTAN

    PDF Supplier PDF
    URL Supplier Web Content
    25099
    Active
    2011-06-30
    Complete
    2017-10-27
    2017-10-06
    II
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    Looking for Drug Master Files (DMF) for 25099 of Alembic Pharmaceuticals Ltd

    Looking for Drug Master Files (DMF) for 25099 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 BOSENTAN, with a corresponding US DMF Number 25099.

    Remarkably, this DMF maintains an Active status since its submission on June 30, 2011, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 27, 2017, and payment made on October 06, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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