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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Hubei Gedian Humanwell Pharmaceutical to the U.S. FDA. Original Data : FDA Website

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    01 16A-HYDROXYPREDNISOLONE (INTERMEDIATE) (1)

    02 16ALPHA-HYDROXYPREDNISOLONE (1)

    03 ABIRATERONE ACETATE (1)

    04 BUDESONIDE (1)

    05 DIENOGEST (1)

    06 DIHYDROFINASTERIDE (1)

    07 DUTASTERIDE (1)

    08 DUTASTERIDE ACID (1)

    09 FINASTERIDE (1)

    10 LEVONORGESTREL (1)

    11 MEDROXYPROGESTERONE ACETATE (1)

    12 MIRABEGRON (1)

    13 NINTEDANIB ESYLATE (1)

    14 OXCARBAZEPINE (1)

    15 PROGESTERONE (1)

    16 PROGESTERONE (PROCESS II) (1)

    17 TESTOSTERONE (1)

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    01 HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTD (14)

    02 HUBEI HUMANWELL CHENGTIAN PHARMACEUTICAL CO LTD (1)

    03 HUBEI ZHUXI HUMANWELL PHARMACEUTICAL CO LTD (2)

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    01 Complete (10)

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    • FDA
    • EDQM
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    Digital Content Digital Content

    16A-HYDROXYPREDNISOLONE (INTERMEDIA...

    PDF Supplier PDF
    URL Supplier Web Content
    HUBEI GEDIAN HUMANWEL...
    Active
    33602
    N/A
    2019-03-27
    II
    Hubei Gedian Humanwell Pharmaceutical

    CPhI North America

    Booth #646

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    • FDA
    • EDQM
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    Contact Supplier Contact Supplier
    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    16ALPHA-HYDROXYPREDNISOLONE

    PDF Supplier PDF
    URL Supplier Web Content
    HUBEI GEDIAN HUMANWEL...
    Active
    27423
    N/A
    2013-08-26
    II
    Hubei Gedian Humanwell Pharmaceutical

    CPhI North America

    Booth #646

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    Contact Supplier Contact Supplier
    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    ABIRATERONE ACETATE

    PDF Supplier PDF
    URL Supplier Web Content
    HUBEI ZHUXI HUMANWELL...
    Active
    37965
    N/A
    2023-01-16
    II
    Hubei Gedian Humanwell Pharmaceutical

    CPhI North America

    Booth #646

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    Contact Supplier
    • FDA
    • EDQM
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    BUDESONIDE

    PDF Supplier PDF
    URL Supplier Web Content
    HUBEI GEDIAN HUMANWEL...
    Active
    34268
    Complete
    2022-08-03
    2022-04-21
    2019-10-29
    II
    Hubei Gedian Humanwell Pharmaceutical

    CPhI North America

    Booth #646

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    DIENOGEST

    PDF Supplier PDF
    URL Supplier Web Content
    HUBEI GEDIAN HUMANWEL...
    Active
    37957
    N/A
    2023-01-18
    II
    Hubei Gedian Humanwell Pharmaceutical

    CPhI North America

    Booth #646

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    • FDA
    • EDQM
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    DIHYDROFINASTERIDE

    PDF Supplier PDF
    URL Supplier Web Content
    HUBEI GEDIAN HUMANWEL...
    Active
    29764
    N/A
    2015-09-20
    II
    Hubei Gedian Humanwell Pharmaceutical

    CPhI North America

    Booth #646

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    • FDA
    • EDQM
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    Digital Content Digital Content

    DUTASTERIDE

    PDF Supplier PDF
    URL Supplier Web Content
    HUBEI GEDIAN HUMANWEL...
    Active
    26803
    Complete
    2021-06-24
    2021-04-02
    2013-01-09
    II
    Hubei Gedian Humanwell Pharmaceutical

    CPhI North America

    Booth #646

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    • FDA
    • EDQM
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    DUTASTERIDE ACID

    PDF Supplier PDF
    URL Supplier Web Content
    HUBEI GEDIAN HUMANWEL...
    Active
    27763
    N/A
    2013-12-16
    II
    Hubei Gedian Humanwell Pharmaceutical

    CPhI North America

    Booth #646

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    FINASTERIDE

    PDF Supplier PDF
    URL Supplier Web Content
    HUBEI GEDIAN HUMANWEL...
    Active
    25056
    Complete
    2022-09-27
    2022-08-04
    2011-06-17
    II
    Hubei Gedian Humanwell Pharmaceutical

    CPhI North America

    Booth #646

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    • FDA
    • EDQM
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    LEVONORGESTREL

    PDF Supplier PDF
    URL Supplier Web Content
    HUBEI GEDIAN HUMANWEL...
    Active
    33000
    Complete
    2022-12-02
    2022-08-15
    2022-06-24
    II
    Hubei Gedian Humanwell Pharmaceutical

    CPhI North America

    Booth #646

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