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    141,959 Orion Corporation A shares converted into B shares

    23 Jun 2025

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    CHMP Recommends Darolutamide for Advanced Prostate Cancer

    21 Jun 2025

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    Orion, Glykos Extend Pact For Next-Gen ADC Development

    17 Jun 2025

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    Orion is a globally operating Finnish pharmaceutical company - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are neurological disorders, oncology and respiratory diseases for which Orion develops inhaled pulmonary medication. Orion's customers are mainly healthcare service providers and professionals such as specialist and general practitioners, veterinarians, pharmacies, hospitals, healthcare centres, clinics, etc.

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    Orion CorporationFinland Flag
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    Finland
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    Head officeOrion CorporationOrionintie 1A, FI-02200 Espoo, FinlandP.O.Box 65, ...
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    +358 10 4261
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    fermionSales@fermion.fi
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    https://www.orion.fi/en/
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    https://www.linkedin.com/company/orion-corporation/
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    DATA COMPILATION #PharmaFlow

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    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. 
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    NEWS #PharmaBuzz

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    141,959 Orion Corporation A shares converted into B shares
    141,959 Orion Corporation A shares converted into B shares

    23 Jun 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/06/23/3103111/0/en/141-959-Orion-Corporation-A-shares-converted-into-B-shares.html

    GLOBENEWSWIRE
    23 Jun 2025
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    CHMP Recommends Darolutamide for Advanced Prostate Cancer
    CHMP Recommends Darolutamide for Advanced Prostate Cancer

    21 Jun 2025

    // PRESS RELEASE

    https://www.orionpharma.com/newsroom/all-news/releases/press-releases/2025/chmp-recommends-third-indication-for-darolutamide-for-patients-with-advanced-prostate-cancer/

    PRESS RELEASE
    21 Jun 2025
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    Orion, Glykos Extend Pact For Next-Gen ADC Development
    Orion, Glykos Extend Pact For Next-Gen ADC Development

    17 Jun 2025

    // PRESS RELEASE

    https://www.orionpharma.com/newsroom/all-news/releases/press-releases/2025/orion-and-glykos-announce-the-extension-of-their-research-collaboration-and-licensing-agreement-for-the-development-of-next-generation-adcs/

    PRESS RELEASE
    17 Jun 2025
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    U.S. FDA approves darolutamide for advanced prostate cancer
    U.S. FDA approves darolutamide for advanced prostate cancer

    03 Jun 2025

    // PRESS RELEASE

    https://www.orionpharma.com/newsroom/all-news/releases/press-releases/2025/u.s.-fda-approves-third-indication-of-darolutamide-for-patients-with-advanced-prostate-cancer

    PRESS RELEASE
    03 Jun 2025
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    Orion Announces Agreement with Shilpa Medicare
    Orion Announces Agreement with Shilpa Medicare

    23 May 2025

    // PRESS RELEASE

    https://www.orionpharma.com/newsroom/all-news/releases/press-releases/2025/orion-announces-agreement-with-shilpa-medicare-for-recombinant-human-albumin-for-european-market/

    PRESS RELEASE
    23 May 2025
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    Orion to host Capital Markets Day today, 22 May 2025, in Helsinki
    Orion to host Capital Markets Day today, 22 May 2025, in Helsinki

    22 May 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/05/22/3086316/0/en/Orion-to-host-Capital-Markets-Day-today-22-May-2025-in-Helsinki.html

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    22 May 2025
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    FDA Orange Book

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    Brand Name : STALEVO 50

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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : STALEVO 50

    Dosage Strength : 12.5MG;200MG;50MG

    Approval Date : 2003-06-11

    Application Number : 21485

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    Brand Name : STALEVO 100

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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : STALEVO 100

    Dosage Strength : 25MG;200MG;100MG

    Approval Date : 2003-06-11

    Application Number : 21485

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    Brand Name : STALEVO 150

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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : STALEVO 150

    Dosage Strength : 37.5MG;200MG;150MG

    Approval Date : 2003-06-11

    Application Number : 21485

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    Brand Name : STALEVO 200

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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : STALEVO 200

    Dosage Strength : 50MG;200MG;200MG

    Approval Date : 2007-08-02

    Application Number : 21485

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    Brand Name : STALEVO 75

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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : STALEVO 75

    Dosage Strength : 18.75MG;200MG;75MG

    Approval Date : 2008-08-29

    Application Number : 21485

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    Brand Name : STALEVO 125

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    RLD : Yes

    TE Code : AB

    CARBIDOPA; ENTACAPONE; LEVODOPA

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : STALEVO 125

    Dosage Strength : 31.25MG;200MG;125MG

    Approval Date : 2008-08-29

    Application Number : 21485

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    Brand Name : COMTAN

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    RLD : Yes

    TE Code : AB

    ENTACAPONE

    Orion Corporation

    Dosage Form : TABLET; ORAL

    Proprietary Name : COMTAN

    Dosage Strength : 200MG

    Approval Date : 1999-10-19

    Application Number : 20796

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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