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    List of Drug Master Files (DMF) for 27143 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Acebright India Pharma Private Limited

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    TENOFOVIR DISOPROXIL FUMARATE [DRUG SUBSTANCE(NON-STERILE)]

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    27143
    Active
    2013-05-08
    Complete
    2017-07-26
    2016-09-23
    II
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    Looking for Drug Master Files (DMF) for 27143 of Acebright India Pharma Private Ltd

    Looking for Drug Master Files (DMF) for 27143 of Acebright India Pharma Private Ltd 1

    20

    Acebright India Pharma Private 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 TENOFOVIR DISOPROXIL FUMARATE [DRUG SUBSTANCE(NON-STERILE)], with a corresponding US DMF Number 27143.

    Remarkably, this DMF maintains an Active status since its submission on May 08, 2013, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 26, 2017, and payment made on September 23, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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