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    List of Drug Master Files (DMF) for 23028 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    DICLOFENAC POTASSIUM USP

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    23028
    Active
    2009-08-12
    Complete
    2017-10-27
    2017-10-16
    II
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    Looking for Drug Master Files (DMF) for 23028 of Amoli Organics Private Ltd

    Looking for Drug Master Files (DMF) for 23028 of Amoli Organics Private Ltd 1

    20

    Amoli Organics 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 DICLOFENAC POTASSIUM USP, with a corresponding US DMF Number 23028.

    Remarkably, this DMF maintains an Active status since its submission on August 12, 2009, 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 16, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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