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    Hubei Gedian Humanwell-PSE
    News
    CPHI & PMEC China 2024 Ended Successfully

    09 Jul 2024

    // PRESS RELEASE

    Gedian Humanwell successfully passed the EDQM audit

    06 Jun 2024

    // PRESS RELEASE

    2024 CPhI Exhibition Shanghai

    22 May 2024

    // PRESS RELEASE

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    Hubei Gedian Humanwell Pharmaceutical

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    ACTIVE PHARMA INGREDIENTS

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    01 1Abiraterone Acetate

    02 1Abiraterone Decanoate

    03 1Apalutamide

    04 1Baloxavir Marboxil

    05 1Budesonide

    06 1Cariprazine Hydrochloride

    07 1Clascoterone

    08 2Cyproterone Acetate

    09 1Desonide

    10 1Dienogest

    11 1Drospirenone

    12 2Dutasteride

    13 1Eplerenone

    14 1Escitalopram Oxalate

    15 1Eslicarbazepine Acetate

    16 1Estradiol

    17 1Estradiol Valerate

    18 1Estriol

    19 1Estrone

    20 1Ethinyl Estradiol

    21 1Exemestane

    22 2Finasteride

    23 1Fluticasone Furoate

    24 1Fluticasone Propionate

    25 1Fulvestrant

    26 1Ganciclovir

    27 1Ganciclovir Sodium

    28 1Gestodene

    29 1Lasmiditan

    30 1Levonorgestrel

    31 1Luliconazole

    32 1Medroxyprogesterone Acetate

    33 1Megestrol Acetate

    34 1Methylprednisolone

    35 1Methylprednisolone Aceponate

    36 1Methylprednisolone Hemisuccinate

    37 1Mifepristone

    38 1Mirabegron

    39 1Nintedanib Esylate

    40 1Oseltamivir Phosphate

    41 2Oxcarbazepine

    42 1Phloroglucinol

    43 1Prasterone Acetate

    44 1Prednisolone

    45 1Pregnenolone

    46 2Progesterone

    47 1Relugolix

    48 1Revefenacin

    49 1Tadalafil

    50 1Testosterone

    51 1Testosterone Acetate

    52 1Testosterone Cypionate

    53 1Testosterone Decanoate

    54 1Testosterone Dodecanoate

    55 1Testosterone Enanthate

    56 1Testosterone Isocaproate

    57 1Testosterone Propionate

    58 2Testosterone Undecanoate

    59 1Tibolone

    60 1Ursodeoxycholic Acid

    61 1Valganciclovir Hydrochloride

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    01

    Finasteride

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Pharma, Lab & Chemical Expo
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    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    Digital Content Digital Content
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-09-27

    Pay. Date : 2022-08-04

    DMF Number : 25056

    Submission : 2011-06-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-238 - Rev 00

    Issue Date : 2020-05-28

    Type : Chemical

    Substance Number : 1615

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10079

    Registrant's Address : GEDIAN ECONOMIC DEVELOPMENT DISTRICT 436070, E-zhou, Hubei, China

    Initial Date of Registration : 2018-07-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-13

    Valid Till : 2026-11-12

    Written Confirmation Number : HB230032

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 51508-001

    Start Marketing Date : 2012-07-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Daewoong Bio Co., Ltd.

    Registration Date : 2014-07-25

    Registration Number : 20140725-94-E-119-10

    Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

    Manufacturer Address : No.25 Juxian Road, Gedian Economic Development District, E-zhou City, Hubei Province, China

     VMF Others AUDIT
    Hubei Gedian Humanwell Pharmaceutical

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    02

    Budesonide

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Pharma, Lab & Chemical Expo
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    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-08-03

    Pay. Date : 2022-04-21

    DMF Number : 34268

    Submission : 2019-10-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-295 - Rev 01

    Issue Date : 2024-05-13

    Type : Chemical

    Substance Number : 1075

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-13

    Valid Till : 2026-11-12

    Written Confirmation Number : HB230032

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 51508-004

    Start Marketing Date : 2013-12-20

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2021-03-29

    Registration Number : 20210329-209-J-903

    Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

    Manufacturer Address : Gedian Economic Development District, E-zhou City, Hubei Province, China

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    03

    Levonorgestrel

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Pharma, Lab & Chemical Expo
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    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-12-02

    Pay. Date : 2022-08-15

    DMF Number : 33000

    Submission : 2022-06-24

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-199 - Rev 00

    Issue Date : 2023-05-19

    Type : Chemical

    Substance Number : 926

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-13

    Valid Till : 2026-11-12

    Written Confirmation Number : HB230032

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 51508-012

    Start Marketing Date : 2022-03-08

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    04

    Progesterone

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Pharma, Lab & Chemical Expo
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    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-10-25

    Pay. Date : 2018-07-27

    DMF Number : 27668

    Submission : 2013-11-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-328 - Rev 00

    Issue Date : 2020-05-26

    Type : Chemical

    Substance Number : 429

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-13

    Valid Till : 2026-11-12

    Written Confirmation Number : HB230032

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 51508-002

    Start Marketing Date : 2012-07-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (5kg/5kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Dienogest

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Pharma, Lab & Chemical Expo
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    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
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37957

    Submission : 2023-01-18

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-045 - Rev 00

    Issue Date : 2024-02-15

    Type : Chemical

    Substance Number : 2732

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Hubei Gedian Humanwell Pharmaceutical

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    06

    Dutasteride

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Pharma, Lab & Chemical Expo
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    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
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-06-24

    Pay. Date : 2021-04-02

    DMF Number : 26803

    Submission : 2013-01-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-298 - Rev 01

    Issue Date : 2021-07-05

    Type : Chemical

    Substance Number : 2641

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51508-006

    Start Marketing Date : 2015-02-11

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2023-12-13

    Registration Number : Su289-17-ND

    Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

    Manufacturer Address : No. 25, Juxian Road, Gedian Economic Development District, E-Zhou City, Hubei Province, PR China

     VMF Others AUDIT
    Hubei Gedian Humanwell Pharmaceutical

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    Market
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    07

    Oxcarbazepine

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    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
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-04-12

    Pay. Date : 2019-02-12

    DMF Number : 32999

    Submission : 2018-07-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-165 - Rev 03

    Issue Date : 2024-11-21

    Type : Chemical

    Substance Number : 2577

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51508-008

    Start Marketing Date : 2019-07-17

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2023-11-06

    Registration Number : 20231106-209-J-1317

    Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

    Manufacturer Address : No. 199, Jianshe Avenue, Gedian Economic Development District, E-zhou City, Hubei Province

     VMF Others AUDIT
    Hubei Gedian Humanwell Pharmaceutical

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    Market
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    08

    Progesterone

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    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
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-03-11

    Pay. Date : 2021-01-12

    DMF Number : 33003

    Submission : 2018-07-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-166 - Rev 03

    Issue Date : 2024-08-20

    Type : Chemical

    Substance Number : 429

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51508-002

    Start Marketing Date : 2012-07-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (5kg/5kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    09

    Testosterone

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Pharma, Lab & Chemical Expo
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    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    Flag China
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    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-07-05

    Pay. Date : 2023-05-26

    DMF Number : 37074

    Submission : 2022-09-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-181 - Rev 01

    Issue Date : 2024-07-23

    Type : Chemical

    Substance Number : 1373

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 70492-002

    Start Marketing Date : 2018-08-31

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT
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    10

    Abiraterone Acetate

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Pharma, Lab & Chemical Expo
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    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37965

    Submission : 2023-01-16

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Contact Hubei Gedian Humanwell Pharmaceutical and get a quotation

    Hubei Gedian Humanwell Pharmaceutical is a supplier offers 65 products (APIs, Excipients or Intermediates).

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