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    Phytex exceeds expectations in removal of Pyrrolizidine Alkaloids

    29 Sep 2022

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    Phytex announces Atropine Base & Atropine Sulfate for supply

    20 Jan 2022

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    Setting quality standards worldwide

    17 Nov 2021

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    Experts in producing high-quality APIs from natural sources, specializing in advanced extraction and isolation techniques.

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    Phytex Australia specializes in the contract manufacturing of Active Pharmaceutical Ingredients (APIs) derived from natural resources for global pharmaceutical and research markets. The company focuses on the discovery and sustainable extraction of niche Australian botanicals, with expertise in alkaloids, glycosides, and steroidal compounds. Operations span from research and development to commercial production, following cGMP, ICH, and 21CFR guidelines, and are supported by regulatory approvals from TGA, US FDA, and EDQM. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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    Phytex AustraliaAustralia Flag
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    Australia
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    PO Box 37 Peakhurst NSW 2210
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    +61 295331324
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    richard@phytex.com.au
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    https://www.phytex.com.au/
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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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    Phytex exceeds expectations in removal of Pyrrolizidine Alkaloids
    Phytex exceeds expectations in removal of Pyrrolizidine Alkaloids

    29 Sep 2022

    // PRESS RELEASE

    https://www.phytex.com.au/post/phytex-exceeds-expectations-in-removal-of-pyrrolizidine-alkaloids

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    29 Sep 2022
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    Phytex announces Atropine Base & Atropine Sulfate for supply
    Phytex announces Atropine Base & Atropine Sulfate for supply

    20 Jan 2022

    // PRESS RELEASE

    https://www.phytex.com.au/post/design-a-stunning-blog

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    20 Jan 2022
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    Setting quality standards worldwide
    Setting quality standards worldwide

    17 Nov 2021

    // PRESS RELEASE

    https://www.phytex.com.au/post/grow-your-blog-community

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    17 Nov 2021
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    USDMF

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    Castanospermine

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10880

    Submission : 1994-04-25

    Status : Active

    Type : II

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    Methscopolamine Bromide

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-02-17

    Pay. Date : 2021-09-16

    DMF Number : 7410

    Submission : 1988-03-30

    Status : Active

    Type : II

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    Scopolamine Base

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    Virtual BoothExperts in producing high-quality APIs from natural sources, specializing in advanced extraction and isolation techniques.

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-05-06

    Pay. Date : 2015-06-30

    DMF Number : 7408

    Submission : 1988-03-30

    Status : Active

    Type : II

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    Scopolamine Hydrobromide

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    Phytex Australia

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7415

    Submission : 1988-03-30

    Status : Active

    Type : II

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    05

    Scopolamine Methonitrate

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    Virtual BoothExperts in producing high-quality APIs from natural sources, specializing in advanced extraction and isolation techniques.

    Phytex Australia

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 7417

    Submission : 1988-03-30

    Status : Active

    Type : II

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    Phytex Australia is a supplier offers 9 products (APIs, Excipients or Intermediates).

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