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    List of Drug Master Files (DMF) for 32048 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Changzhou Pharmaceutical Factory

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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 Changzhou Pharmaceutical Factory (1)

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    01 SOFOSBUVIR (AMORPHOUS) (1)

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    CHANGZHOU PHARMACEUTICAL FACTORY

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    SOFOSBUVIR (AMORPHOUS)

    PDF Supplier PDF
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    32048
    Active
    2017-09-06
    Complete
    2018-01-24
    2017-09-15
    II
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    Looking for Drug Master Files (DMF) for 32048 of Changzhou Pharmaceutical Factory

    Looking for Drug Master Files (DMF) for 32048 of Changzhou Pharmaceutical Factory 1

    20

    Changzhou Pharmaceutical Factory, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is SOFOSBUVIR (AMORPHOUS), with a corresponding US DMF Number 32048.

    Remarkably, this DMF maintains an Active status since its submission on September 06, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2018, and payment made on September 15, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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