menu
    • menu

    Company profile for Hubei Gedian Humanwell Pharmaceutical

    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

    DATA COMPILATION
    #PharmaFlow

    Hubei Gedian Humanwell Pharmaceutical

    Contact Supplier

    Website

    CPhI India 2024

    Attending

    Book a meeting

    envelop Contact Supplier

    Latest Content by PharmaCompass

    radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities

    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

    Key Products KEY PRODUCTS

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

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

    Related CompaniesRelated Companies

    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.

    CONTACT DETAILS

    Click the arrow to open the dropdown
    Contact SupplierContact
    Google MapGoogle Map
    Full View ScreenFull View Screen
    Hubei Gedian Humanwell PharmaceuticalChina Flag
    Country
    Country
    China
    Address
    Address
    No.77, Optical Valley Seventh Road, East Lake High-tech District, Wuhan, 43020...
    Telephone
    Telephone
    +86 2787596825
    Client Email
    Email
    sales@steroid-chem.com
    Client Website
    Website
    https://www.steroid-chem.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/hubei-gedian-humanwell-pharmaceutical-co-ltd/
    youtube
    YouTube
    Twitter
    Twitter
    Contact Info
    Others

    Events

    Webinars & Exhibitions

    Request a meetingRequest a meeting
    Full Screen ViewFull Screen View
    cphi-india-2024-91846.png

    CPhI India 2024

    Attending

    envelop Contact Supplier

    CPhI India 2024

    Contact Supplier

    Meeting

    Digital content read-more

    Explore the latest content creation from this company

    CORPORATE CONTENT #SupplierSpotlight

    Product List 2023

    read-more

      https://www.pharmacompass.com/pdf/party/content/hubei-gedian-humanwell-pharmaceutical-party-content-26038.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    Corporate Presentation

    read-more

      https://www.pharmacompass.com/pdf/party/content/hubei-gedian-humanwell-pharmaceutical-party-content-51834.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    WC Certificate

    read-more

      https://www.pharmacompass.com/pdf/party/content/hubei-gedian-humanwell-pharmaceutical-party-content-12199.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    DATA COMPILATION #PharmaFlow

    read-more
    read-more
    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.   
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 6088

    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

    #PharmaFlow by PHARMACOMPASS
    24 Oct 2024
    Share Share

    NEWS #PharmaBuzz

    read-more
    read-more
    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
    Share Share
    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
    Share Share
    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
    Share Share

    KEY PRODUCTS

    read-more
    read-more

    TOP RANKED SUPPLIER FOR:

    Sponsored Ads.
    full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view
    Sponsored Ads.full-view

    Excipients

    Discover the DDS // excipients from this company

    Inspections and registrations

    Check the inspections & registration from this company

    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

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

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

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

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

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

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

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

    Find a price of Abiraterone Acetate bulk with DMF offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Cyproterone Acetate bulk with CEP offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Dutasteride bulk with DMF offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Finasteride bulk with DMF offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Lasmiditan bulk with DMF offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Medroxyprogesterone Acetate bulk with DMF offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Mirabegron bulk with DMF offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Nintedanib Esylate bulk with DMF offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Oxcarbazepine bulk with CEP offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Prednisolone bulk with DMF offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Cyproterone Acetate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Abiraterone Decanoate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Apalutamide bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Baloxavir Marboxil bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Cariprazine Hydrochloride bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Clascoterone bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Desonide bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Drospirenone bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Eplerenone bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Escitalopram Oxalate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Eslicarbazepine Acetate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Estradiol bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Estradiol Valerate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Estriol bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Ethinyl Estradiol bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Exemestane bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Fluticasone Furoate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Fluticasone Propionate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Fulvestrant bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Ganciclovir bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Ganciclovir Sodium bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Gestodene bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Luliconazole bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Megestrol Acetate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Methylprednisolone bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Methylprednisolone Aceponate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Methylprednisolone Hemisuccinate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Mifepristone bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Oseltamivir Phosphate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Phloroglucinol bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Prasterone Acetate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Pregnenolone bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Relugolix bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Revefenacin bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Tadalafil bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Testosterone Acetate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Testosterone Cypionate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Testosterone Decanoate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Testosterone Dodecanoate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Testosterone Enanthate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Testosterone Isocaproate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Testosterone Propionate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Testosterone Undecanoate bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Tibolone bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Ursodeoxycholic Acid bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Find a price of Valganciclovir Hydrochloride bulk offered by Hubei Gedian Humanwell Pharmaceutical

    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search