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    List of Drug Master Files (DMF) for 27909 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Alkem Laboratories

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    ARIPIPRAZOLE USP

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    27909
    Active
    2014-02-13
    Complete
    2014-07-07
    2014-04-21
    II
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    Looking for Drug Master Files (DMF) for 27909 of Alkem Laboratories Ltd

    Looking for Drug Master Files (DMF) for 27909 of Alkem Laboratories Ltd 1

    20

    Alkem Laboratories 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 ARIPIPRAZOLE USP, with a corresponding US DMF Number 27909.

    Remarkably, this DMF maintains an Active status since its submission on February 13, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 07, 2014, and payment made on April 21, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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