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    List of Drug Master Files (DMF) for 28506 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Chongqing Huapont Pharmaceutical

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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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    01 Chongqing Huapont Pharmaceutical (1)

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    01 ROFLUMILAST (1)

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    CHONGQING HUAPONT PHARMACEUTICAL CO...

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    ROFLUMILAST

    PDF Supplier PDF
    URL Supplier Web Content
    28506
    Active
    2014-07-22
    Complete
    2015-01-21
    2014-09-10
    II
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    Looking for Drug Master Files (DMF) for 28506 of Chongqing Huapont Pharmaceutical Co Ltd

    Looking for Drug Master Files (DMF) for 28506 of Chongqing Huapont Pharmaceutical Co Ltd 1

    20

    Chongqing Huapont Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is ROFLUMILAST, with a corresponding US DMF Number 28506.

    Remarkably, this DMF maintains an Active status since its submission on July 22, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 21, 2015, and payment made on September 10, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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