menu
    • menu

    Company profile for Amsa

    Mix Gif-PSE
    News
    BMS Expands AI Integration System-Wide with Anthropic Claude

    21 May 2026

    // FIERCE PHARMA

    Incyte, Genesis Expand Molecular AI For Drug Discovery

    21 May 2026

    // BUSINESSWIRE

    Dr Reddy's launches oral semaglutide biosimilar Obeda in India

    21 May 2026

    // ECONOMICTIMES

    DATA COMPILATION
    #PharmaFlow

    Amsa

    Contact Supplier

    Website

    PEGS Boston Summit

    Not Confirmed

    Book a meeting

    envelop Contact Supplier

    Latest Content by PharmaCompass

    radio-compass-blog/prostaglandin-market-to-cross-us-1-27-bn-by-2035-liquidia-s-yutrepia-okayed-for-pulmonary-hypertension

    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass
    Related CompaniesRelated Companies

    About

    AMSA S.p.A, founded in 1953 near Italy’s iconic Lake Como, is the founding manufacturing company of the CFM Group. With a modernized facility and over six decades of experience, AMSA specializes in the production of small- to medium-volume APIs for both generic and custom synthesis markets. The site holds a 60,000L capacity and earned US FDA approval in 1998. AMSA continues to deliver high-quality pharmaceutical ingredients with a strong focus on innovation, compliance, and customer satisfaction.

    CONTACT DETAILS

    Click the arrow to open the dropdown
    Contact SupplierContact
    Google MapGoogle Map
    Full View ScreenFull View Screen
    AmsaItaly Flag
    Country
    Country
    Italy
    Address
    Address
    Viale del Ghisallo 20, 20151 Milano (MI) 601857
    Telephone
    Telephone
    +39 023925326
    Client Email
    Email
    sales@cosma.it
    Client Website
    Website
    https://www.cfm-group.it/amsa/
    Linkedin
    Linkedin
    youtube
    YouTube
    Twitter
    Twitter
    Contact Info
    Others

    Events

    Webinars & Exhibitions

    Request a meetingRequest a meeting
    Full Screen ViewFull Screen View
    PEGS Boston Summit

    PEGS Boston Summit

    Not Confirmed

    envelop Contact Supplier

    PEGS Boston Summit

    Post an Enquiry

    Meeting

    Digital content read-more

    Explore the latest content creation from this company

    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: 16164

    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

    Inspections and registrations

    Check the inspections & registration from this company
    Popup

    ABOUT THIS PAGE

    Contact Amsa and get a quotation

    Amsa is a supplier offers 22 products (APIs, Excipients or Intermediates).

    Find Flecainide bulk with DMF, CEP, JDMF offered by Amsa

    Find Meloxicam bulk with DMF, CEP, JDMF offered by Amsa

    Find Metoclopramide Hydrochloride bulk with CEP, JDMF offered by Amsa

    Find Amantadine Hydrochloride bulk with DMF offered by Amsa

    Find Etodolac bulk with DMF offered by Amsa

    Find Glipizide bulk with DMF offered by Amsa

    Find Glycopyrronium Bromide bulk with DMF offered by Amsa

    Find Levodropropizine bulk with CEP offered by Amsa

    Find Lurasidone Hydrochloride bulk with DMF offered by Amsa

    Find Memantine Hydrochloride bulk with DMF offered by Amsa

    Find Metoclopramide bulk with JDMF offered by Amsa

    Find Bromhexine Hydrochloride bulk offered by Amsa

    Find Cysteamine Bitartrate bulk offered by Amsa

    Find Cysteamine Hydrochloride bulk offered by Amsa

    Find Diclofenac Epolamine bulk offered by Amsa

    Find Etodolac bulk offered by Amsa

    Find Glipizide bulk offered by Amsa

    Find Glycopyrronium Bromide bulk offered by Amsa

    Find Imepitoin bulk offered by Amsa

    Find Meloxicam bulk offered by Amsa

    Find Oxantel Pamoate bulk offered by Amsa

    Find Viloxazine Hydrochloride bulk offered by Amsa

    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
    • Privacy policy
    • Terms and conditions
    • Disclaimers
    • LinkedIn
    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search