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    List of Drug Master Files (DMF) for 24312 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    ATORVASTATIN CALCIUM CRYSTALLINE USP (ATVR)

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    24312
    Active
    2010-12-01
    Complete
    2020-08-24
    2020-08-19
    II
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    Looking for Drug Master Files (DMF) for 24312 of Arch Pharmalabs Ltd

    Looking for Drug Master Files (DMF) for 24312 of Arch Pharmalabs Ltd 1

    20

    Arch Pharmalabs 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 ATORVASTATIN CALCIUM CRYSTALLINE USP (ATVR), with a corresponding US DMF Number 24312.

    Remarkably, this DMF maintains an Active status since its submission on December 01, 2010, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 24, 2020, and payment made on August 19, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II

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