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    List of Drug Master Files (DMF) for 27164 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Amoli Organics

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    OLMESARTAN MEDOXOMIL USP

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    27164
    Active
    2013-05-21
    Complete
    2014-06-11
    2014-05-19
    II
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    Looking for Drug Master Files (DMF) for 27164 of Amoli Organics Pvt Ltd

    Looking for Drug Master Files (DMF) for 27164 of Amoli Organics Pvt Ltd 1

    20

    Amoli Organics Pvt 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 OLMESARTAN MEDOXOMIL USP, with a corresponding US DMF Number 27164.

    Remarkably, this DMF maintains an Active status since its submission on May 21, 2013, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 11, 2014, and payment made on May 19, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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