Please Wait
Applying Filters...
menu
    • menu
    Farmhispania-PSE
    News
    FHG To Sponsor Fèlix Serratosa Conference

    30 Jan 2023

    // PRESS RELEASE

    FHG's Montmeló site successfully inspected by ANVISA

    14 Nov 2022

    // PRESS RELEASE

    Farmhispania Group has Awarded With The First CEP For Everolimus

    02 Feb 2021

    // PRESS RELEASE

    Data Compilation
    #PharmaFlow

    Farmhispania

    Contact Supplier

    Website

    Antibody Engineering

    Not Confirmed

    Book a meeting

    envelop Contact Supplier

    Latest Content by PharmaCompass

    speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility
    Menu

    Farmhispania

    EVENTS

    • Webinars & Exhibitions

    PRESENTATION(s)

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    Key Products KEY PRODUCTS

    SERVICES

    Key Services KEY SERVICES

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Filters

    clear-filterReset all filters
    Left Arrow
    Right Arrow

    Digital content

    Explore the latest content creation from this company

    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

    read-more

      https://www.pharmacompass.com/pdf/party/content/farmhispania-party-content-58506.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    GMP Certificate 2023

    read-more

      https://www.pharmacompass.com/pdf/party/content/farmhispania-party-content-38064.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: 6502

    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
    FHG To Sponsor Fèlix Serratosa Conference
    FHG To Sponsor Fèlix Serratosa Conference

    30 Jan 2023

    // PRESS RELEASE

    https://www.farmhispaniagroup.com/fhg-to-sponsor-felix-serratosa-conference/

    PRESS RELEASE
    30 Jan 2023
    Share Share
    FHG's Montmeló site successfully inspected by ANVISA
    FHG's Montmeló site successfully inspected by ANVISA

    14 Nov 2022

    // PRESS RELEASE

    https://www.farmhispaniagroup.com/fhgs-montmelo-site-successfully-inspected-by-anvisa/

    PRESS RELEASE
    14 Nov 2022
    Share Share
    Farmhispania Group has Awarded With The First CEP For Everolimus
    Farmhispania Group has Awarded With The First CEP For Everolimus

    02 Feb 2021

    // PRESS RELEASE

    https://www.farmhispaniagroup.com/framhispania-group-awarded-with-the-first-cep-for-everolimus/

    PRESS RELEASE
    02 Feb 2021
    Share Share
    New Multipurpose manufacturing building at Montmeló site (Barcelona)
    New Multipurpose manufacturing building at Montmeló site (Barcelona)

    12 Sep 2020

    // PRESS RELEASE

    https://www.farmhispaniagroup.com/new-multipurpose-manufacturing-building-at-the-montmelo-barcelona-site/

    PRESS RELEASE
    12 Sep 2020
    Share Share
    Medicines for Europe Statement on COVID-19 Coronavirus
    Medicines for Europe Statement on COVID-19 Coronavirus

    16 Mar 2020

    // PRESS RELEASE

    https://www.farmhispaniagroup.com/medicines-for-europe-statement-on-covid-19-coronavirus/

    PRESS RELEASE
    16 Mar 2020
    Share Share
    Farmhispania will attend the 3rd Annual Market High Potent Medicine
    Farmhispania will attend the 3rd Annual Market High Potent Medicine

    04 Dec 2019

    // PRESS RELEASE

    https://www.farmhispaniagroup.com/farmhispania-group-in-the-3rd-annual-markets-and-markets-high-potent-medicines-conference-milan/

    PRESS RELEASE
    04 Dec 2019
    Share Share
    Contact Farmhispania and get a quotation

    Farmhispania is a supplier offers 43 products (APIs, Excipients or Intermediates).

    Find a price of Metformin bulk with DMF, CEP, JDMF offered by Farmhispania

    Find a price of Rocuronium Bromide bulk with DMF, CEP, JDMF offered by Farmhispania

    Find a price of Atracurium Besylate bulk with DMF, CEP offered by Farmhispania

    Find a price of Benazepril Hydrochloride bulk with DMF, CEP offered by Farmhispania

    Find a price of Cisatracurium Besylate bulk with DMF, CEP offered by Farmhispania

    Find a price of Enalapril Maleate bulk with DMF, CEP offered by Farmhispania

    Find a price of Everolimus bulk with DMF, CEP offered by Farmhispania

    Find a price of Gefitinib bulk with CEP, JDMF offered by Farmhispania

    Find a price of Gemcitabine bulk with CEP, JDMF offered by Farmhispania

    Find a price of Milrinone bulk with DMF, JDMF offered by Farmhispania

    Find a price of Pemetrexed Disodium bulk with CEP, JDMF offered by Farmhispania

    Find a price of Sugammadex Sodium bulk with DMF, JDMF offered by Farmhispania

    Find a price of Ramipril bulk with CEP offered by Farmhispania

    Find a price of Captopril bulk with CEP offered by Farmhispania

    Find a price of Decitabine bulk with DMF offered by Farmhispania

    Find a price of Deutetrabenazine bulk with DMF offered by Farmhispania

    Find a price of Metformin bulk with DMF offered by Farmhispania

    Find a price of Quinapril bulk with DMF offered by Farmhispania

    Find a price of Rocuronium Bromide bulk with CEP offered by Farmhispania

    Find a price of Tacrolimus bulk with DMF offered by Farmhispania

    Find a price of GEMCITABINE HYDROCHLORIDE USP bulk with DMF offered by Farmhispania

    Find a price of Atropine bulk offered by Farmhispania

    Find a price of Atropine Sulfate bulk offered by Farmhispania

    Find a price of Cannabidiol bulk offered by Farmhispania

    Find a price of Delapril Hydrochloride bulk offered by Farmhispania

    Find a price of Desloratadine bulk offered by Farmhispania

    Find a price of Deucravacitinib bulk offered by Farmhispania

    Find a price of Loratadine bulk offered by Farmhispania

    Find a price of Methotrexate bulk offered by Farmhispania

    Find a price of Midostaurin bulk offered by Farmhispania

    Find a price of Palonosetron bulk offered by Farmhispania

    Find a price of Perindopril Arginine bulk offered by Farmhispania

    Find a price of Perindopril Erbumine bulk offered by Farmhispania

    Find a price of Pirfenidone bulk offered by Farmhispania

    Find a price of Relugolix bulk offered by Farmhispania

    Find a price of Sirolimus bulk offered by Farmhispania

    Find a price of Staurosporine bulk offered by Farmhispania

    Find a price of Tapentadol bulk offered by Farmhispania

    Find a price of Tetrabenazine bulk offered by Farmhispania

    Find a price of Trandolapril bulk offered by Farmhispania

    Find a price of Valbenazine Tosylate bulk offered by Farmhispania

    Find a price of Vecuronium Bromide bulk offered by Farmhispania

    Find a price of Zavegepant HCl bulk offered by Farmhispania