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    List of Drug Master Files (DMF) for 31789 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Amoli Organics

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    AMOLI ORGANICS PVT LTD

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    SOLIFENACIN SUCCINATE

    PDF Supplier PDF
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    31789
    Active
    2017-08-03
    Complete
    2018-03-26
    2017-12-07
    II
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    Looking for Drug Master Files (DMF) for 31789 of Amoli Organics Pvt Ltd

    Looking for Drug Master Files (DMF) for 31789 of Amoli Organics Pvt Ltd 1

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    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 SOLIFENACIN SUCCINATE, with a corresponding US DMF Number 31789.

    Remarkably, this DMF maintains an Active status since its submission on August 03, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 26, 2018, and payment made on December 07, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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