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    List of Drug Master Files (DMF) for 16053 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    ChemWerth Inc

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

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    01 ChemWerth Inc (1)

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    01 ESMOLOL HCL (1)

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    CHEMWERTH INC

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    ESMOLOL HCL

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    16053
    Active
    2002-06-27
    Complete
    2013-01-18
    2012-12-17
    II
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    Looking for Drug Master Files (DMF) for 16053 of Chemwerth Inc

    Looking for Drug Master Files (DMF) for 16053 of Chemwerth Inc 1

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    Chemwerth Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

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

    One of their notable products is ESMOLOL HCL, with a corresponding US DMF Number 16053.

    Remarkably, this DMF maintains an Active status since its submission on June 27, 2002, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 18, 2013, and payment made on December 17, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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