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    Company profile for Hubei Gedian Humanwell Pharmaceutical

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    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

    DATA COMPILATION
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    Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

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    About

    Hubei Gedian Humanwell Pharmaceutical Co., Ltd. is a modern high-tech pharmaceutical company with a focus on the research and development, production, and sales of fertility regulation drugs and steroidal APIs. It operates as a wholly-owned subsidiary of Humanwell Healthcare Group (Stock Code: 600079), one of the leading pharmaceutical conglomerates in China. The company operates two APIs manufacturing sites, one formulation factory, and one excipients factory, showcasing its commitment to integrating the reproductive health industry chain from raw materials and active pharmaceutical ingredients (APIs) to finished dosage forms.

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    Hubei Gedian Humanwell PharmaceuticalChina Flag
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    China
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    No.77, Optical Valley Seventh Road, East Lake High-tech District, Wuhan, 43020...
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    +86 2787596825
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    sales@steroid-chem.com
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    https://www.steroid-chem.com/
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    https://www.linkedin.com/company/hubei-gedian-humanwell-pharmaceutical-co-ltd/
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    Product List 2023

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    DATA COMPILATION #PharmaFlow

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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    CPHI & PMEC China 2024 Ended Successfully
    CPHI & PMEC China 2024 Ended Successfully

    09 Jul 2024

    // PRESS RELEASE

    https://www.steroid-chem.com/news-show-1034512.html

    PRESS RELEASE
    09 Jul 2024
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    Gedian Humanwell successfully passed the EDQM audit
    Gedian Humanwell successfully passed the EDQM audit

    06 Jun 2024

    // PRESS RELEASE

    https://www.steroid-chem.com/news-show-1034510.html

    PRESS RELEASE
    06 Jun 2024
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    2024 CPhI Exhibition Shanghai
    2024 CPhI Exhibition Shanghai

    22 May 2024

    // PRESS RELEASE

    https://www.steroid-chem.com/news-show-1034361.html

    PRESS RELEASE
    22 May 2024
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    ALL APIs

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

    Product
    Web Link

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    Market
    Place

    02

    Budesonide

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    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

     VMF Others AUDIT
    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Levonorgestrel

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    • EDQM
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    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    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
    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    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.
    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
    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

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    Market
    Place

    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.
    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

    Product
    Web Link

    Stock Recap
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    Market
    Place

    06

    Dutasteride

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Oxcarbazepine

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Progesterone

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    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
    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Testosterone

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    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
    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    10

    Dutasteride

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27763

    Submission : 2013-12-16

    Status : Active

    Type : II

     CEP/COS 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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    Web Link

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    01

    16alpha-hydroxyprednisolone

    China
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

    Hubei Gedian Humanwell Pharmaceutical

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27423

    Submission : 2013-08-26

    Status : Active

    Type : II

    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

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    Market
    Place

    02

    Abiraterone Acetate

    China
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

    Hubei Gedian Humanwell Pharmaceutical

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37965

    Submission : 2023-01-16

    Status : Active

    Type : II

    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Budesonide

    China
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

    Hubei Gedian Humanwell Pharmaceutical

    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-08-03

    Pay. Date : 2022-04-21

    DMF Number : 34268

    Submission : 2019-10-29

    Status : Active

    Type : II

    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

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    Market
    Place

    04

    Dienogest

    China
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

    Hubei Gedian Humanwell Pharmaceutical

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37957

    Submission : 2023-01-18

    Status : Active

    Type : II

    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Dihydrofinasteride

    China
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

    Hubei Gedian Humanwell Pharmaceutical

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 29764

    Submission : 2015-09-20

    Status : Active

    Type : II

    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Dutasteride

    China
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

    Hubei Gedian Humanwell Pharmaceutical

    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-06-24

    Pay. Date : 2021-04-02

    DMF Number : 26803

    Submission : 2013-01-09

    Status : Active

    Type : II

    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Dutasteride Acid

    China
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

    Hubei Gedian Humanwell Pharmaceutical

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27763

    Submission : 2013-12-16

    Status : Active

    Type : II

    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Finasteride

    China
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

    Hubei Gedian Humanwell Pharmaceutical

    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-09-27

    Pay. Date : 2022-08-04

    DMF Number : 25056

    Submission : 2011-06-17

    Status : Active

    Type : II

    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Lasmiditan Hemisuccinate

    China
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

    Hubei Gedian Humanwell Pharmaceutical

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40130

    Submission : 2024-07-27

    Status : Active

    Type : II

    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Levonorgestrel

    China
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

    Hubei Gedian Humanwell Pharmaceutical

    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-12-02

    Pay. Date : 2022-08-15

    DMF Number : 33000

    Submission : 2022-06-24

    Status : Active

    Type : II

    Hubei Gedian Humanwell Pharmaceutical

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    KEY PRODUCTS

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    Excipients

    Discover the DDS // excipients from this company

    All Excipients

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    read-more

    01

    Benzalkonium Chloride

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34431

    Submission : 2020-01-07

    Status : Active

    Type : IV

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Benzyl Benzoate

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34543

    Submission : 2020-12-17

    Status : Active

    Type : IV

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Butyl 4-Hydroxybenzoate

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34432

    Submission : 2020-01-07

    Status : Active

    Type : IV

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Catalase

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34433

    Submission : 2020-01-07

    Status : Active

    Type : IV

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Oleic Acid Excipient

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34481

    Submission : 2020-12-17

    Status : Active

    Type : IV

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Polysorbate API

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33606

    Submission : 2020-01-07

    Status : Active

    Type : IV

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Sesame Oil

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34541

    Submission : 2020-12-17

    Status : Active

    Type : IV

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Squalene

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36346

    Submission : 2021-11-03

    Status : Active

    Type : IV

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Trehalose

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35711

    Submission : 2021-11-03

    Status : Active

    Type : IV

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Venelex

    China

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34542

    Submission : 2020-12-17

    Status : Active

    Type : IV

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    Inspections and registrations

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    ABOUT THIS PAGE

    Contact Hubei Gedian Humanwell Pharmaceutical and get a quotation

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

    Find a price of Finasteride bulk with DMF, CEP, JDMF, WC offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Budesonide bulk with DMF, CEP, WC offered by Hubei Gedian Humanwell Pharmaceutical

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