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    List of Drug Master Files (DMF) for 32794 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    ROSUVASTATIN CALCIUM

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    32794
    Active
    2018-05-17
    Complete
    2019-05-16
    2019-03-18
    II
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    Looking for Drug Master Files (DMF) for 32794 of Amoli Organics Pvt Ltd

    Looking for Drug Master Files (DMF) for 32794 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 ROSUVASTATIN CALCIUM, with a corresponding US DMF Number 32794.

    Remarkably, this DMF maintains an Active status since its submission on May 17, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 16, 2019, and payment made on March 18, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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