Please Wait
Applying Filters...
menu
    • menu
    Default Key Product, Service and Excipients
    News
    Merck, Eisai End Keytruda-Lenvima Collaboration In Liver Cancer

    30 Oct 2025

    // FIERCE PHARMA

    Regeneron Pledges $1B+ For Modex Multispecific Antibodies

    30 Oct 2025

    // FIERCE BIOTECH

    Sk Pharmteco, Lotte Biologics Partner to Enhance Global ADC CDMO

    30 Oct 2025

    // BUSINESSWIRE

    Data Compilation
    #PharmaFlow

    #1

    Contact Supplier

    Website

    CPhI India

    Booth #1.C12

    Book a meeting

    envelop Contact Supplier

    Latest Content by PharmaCompass

    radio-compass-blog/cdmo-activity-tracker-veranova-chemexpress-invest-in-adc-facilities-cohance-to-set-up-oligonucleotide-facility-in-india
    Menu

    Swati Spentose

    EVENTS

    • Webinars & Exhibitions

    PRESENTATION(s)

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    Key Products KEY PRODUCTS

    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

    Corporate Presentation

    read-more

      https://www.pharmacompass.com/pdf/party/content/swati-spentose-party-content-34510.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    DATA COMPILATION #PharmaFlow

    read-more
    read-more
    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 14544

    https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities

    #PharmaFlow by PHARMACOMPASS
    21 Nov 2024
    Share Share
    Contact Swati Spentose and get a quotation

    Swati Spentose is a supplier offers 68 products (APIs, Excipients or Intermediates).

    Find a price of Lidocaine bulk with DMF, CEP, JDMF, WC offered by Swati Spentose

    Find a price of Dutasteride bulk with CEP, JDMF, WC offered by Swati Spentose

    Find a price of Lidocaine Hydrochloride bulk with DMF, CEP, WC offered by Swati Spentose

    Find a price of Melatonin bulk with DMF, CEP, WC offered by Swati Spentose

    Find a price of Meloxicam bulk with DMF, CEP, WC offered by Swati Spentose

    Find a price of Prilocaine bulk with DMF, CEP, WC offered by Swati Spentose

    Find a price of Prilocaine Hydrochloride bulk with DMF, CEP, WC offered by Swati Spentose

    Find a price of Tamsulosin bulk with DMF, CEP, WC offered by Swati Spentose

    Find a price of Glycopyrronium Bromide bulk with DMF, WC offered by Swati Spentose

    Find a price of Granisetron Hydrochloride bulk with DMF, WC offered by Swati Spentose

    Find a price of Pentosan Polysulfate Sodium bulk with DMF, WC offered by Swati Spentose

    Find a price of Silodosin bulk with DMF, WC offered by Swati Spentose

    Find a price of Triamcinolone Acetonide bulk with CEP, WC offered by Swati Spentose

    Find a price of Desogestrel bulk with WC offered by Swati Spentose

    Find a price of Dienogest bulk with WC offered by Swati Spentose

    Find a price of Drospirenone bulk with WC offered by Swati Spentose

    Find a price of Estradiol bulk with WC offered by Swati Spentose

    Find a price of Ethinyl Estradiol bulk with WC offered by Swati Spentose

    Find a price of Finasteride bulk with WC offered by Swati Spentose

    Find a price of Fluocinolone Acetonide bulk with WC offered by Swati Spentose

    Find a price of Gestodene bulk with WC offered by Swati Spentose

    Find a price of Halobetasol bulk with WC offered by Swati Spentose

    Find a price of Levonorgestrel bulk with WC offered by Swati Spentose

    Find a price of Oxymetholone bulk with WC offered by Swati Spentose

    Find a price of Triamcinolone bulk with WC offered by Swati Spentose

    Find a price of Ulipristal Acetate bulk with WC offered by Swati Spentose

    Find a price of Alendronate Sodium bulk offered by Swati Spentose

    Find a price of Articaine Hydrochloride bulk offered by Swati Spentose

    Find a price of Beclomethasone Dipropionate bulk offered by Swati Spentose

    Find a price of Betamethasone bulk offered by Swati Spentose

    Find a price of Betamethasone Dipropionate bulk offered by Swati Spentose

    Find a price of Budesonide bulk offered by Swati Spentose

    Find a price of Bupivacaine bulk offered by Swati Spentose

    Find a price of Bupivacaine Hydrochloride bulk offered by Swati Spentose

    Find a price of Clobetasol Propionate bulk offered by Swati Spentose

    Find a price of Cyproterone Acetate bulk offered by Swati Spentose

    Find a price of Dextrans bulk offered by Swati Spentose

    Find a price of Diphenhydramine bulk offered by Swati Spentose

    Find a price of Diphenhydramine Hydrochloride bulk offered by Swati Spentose

    Find a price of Dutasteride bulk offered by Swati Spentose

    Find a price of Estradiol Valerate bulk offered by Swati Spentose

    Find a price of Fluticasone Propionate bulk offered by Swati Spentose

    Find a price of Glucosamine bulk offered by Swati Spentose

    Find a price of Granisetron bulk offered by Swati Spentose

    Find a price of Hydroxyethyl Starch bulk offered by Swati Spentose

    Find a price of Iron Dextran bulk offered by Swati Spentose

    Find a price of Iron III Hydroxide Polymaltose Complex bulk offered by Swati Spentose

    Find a price of Iron Sucrose bulk offered by Swati Spentose

    Find a price of Lanthanum Carbonate bulk offered by Swati Spentose

    Find a price of Lidocaine bulk offered by Swati Spentose

    Find a price of Lidocaine Hydrochloride bulk offered by Swati Spentose

    Find a price of Mebendazole bulk offered by Swati Spentose

    Find a price of Melatonin bulk offered by Swati Spentose

    Find a price of Meloxicam bulk offered by Swati Spentose

    Find a price of Mometasone Furoate bulk offered by Swati Spentose

    Find a price of Nomegestrol Acetate bulk offered by Swati Spentose

    Find a price of Oxandrolone bulk offered by Swati Spentose

    Find a price of Pentosan Polysulfate Sodium bulk offered by Swati Spentose

    Find a price of Phenytoin bulk offered by Swati Spentose

    Find a price of Phenytoin Sodium bulk offered by Swati Spentose

    Find a price of Piroxicam bulk offered by Swati Spentose

    Find a price of Ropivacaine Hydrochloride bulk offered by Swati Spentose

    Find a price of Stanozolol bulk offered by Swati Spentose

    Find a price of Testosterone bulk offered by Swati Spentose

    Find a price of Testosterone Undecanoate bulk offered by Swati Spentose

    Find a price of Tetracaine bulk offered by Swati Spentose

    Find a price of Tibolone bulk offered by Swati Spentose

    Find a price of Trimegestone bulk offered by Swati Spentose