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    • Focus on natural origin and oncology APIs.

    Setting up R&D and production platform for new salt and crystal form, deep cooperation with clients for IND, NDA, ANDA, 505b(2) or P-IV challenge.

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    About

    ●  Focus on natural origin and oncology APIs, setting up R&D and production platform for new salt and crystal form, deep cooperation with clients for IND, NDA, ANDA, 505b(2) or P-IV challenge.

    ●  Explore the potential of macromolecular APIs, setting up R&D and production platform for Polypeptide & Glycans.

    ●  Global registration platform, professional team,  and international cGMP system.

    ●  API  CDMO service with global registration.

    ●  Strategy: FDF + APIs.


    10

    +

    Average Annual Experience

    20

    +

    Successful Projects

    100

    +

    Registration Countries

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    Product Center

    Commercial Drug Subtance

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    Pipeline Drug Subtance

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    Linker

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    CDMO Service

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    Technical platform

    1

    R&D and Production Platform

    ● IND / NDA (new salts, new crystal form) / ANDA

    ● Polypeptide / Glycans

    ● Playload & Linker


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    2

    International Quality Research and Registration Platform

    ● Experienced registration team with more than 10 years experience, and knowledge of registration-related regulations in China, the US Europe and other countries.

    ● With experience in drug registration in Europe, America, Japan, Eastern Europe, Southeast Asia and other countries, as well as official GMP certifications such as EDQM, FDA, PMDA, NMPA, COFEPRIS, MHRA, etc.

    ● With experience in more than 100 different countries, we can provide different registration services to meet the different needs of our clients.


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    3

    Globle Patent Application and Challenge Platform

    ● Establish and maintain our own Intellectual Property System Architecture.

    ● Focusing on the direction of new salts, new crystal forms, new preparation methods, new compounds, etc., to provide customers with services such as new drug development and ANDA P-IV challenges.


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    News updates

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