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    List of Drug Master Files (DMF) for 29012 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Micro Labs Limited

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    TICAGRELOR

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    29012
    Active
    2015-02-13
    Complete
    2015-05-21
    2015-03-04
    II
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    Looking for Drug Master Files (DMF) for 29012 of Micro Labs Ltd

    Looking for Drug Master Files (DMF) for 29012 of Micro Labs Ltd 1

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    Micro Labs 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 TICAGRELOR, with a corresponding US DMF Number 29012.

    Remarkably, this DMF maintains an Active status since its submission on February 13, 2015, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 21, 2015, and payment made on March 04, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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