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    3. /Hefei Lifeon Pharmaceutical Co., Ltd.
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    Hefei Lifeon Pharmaceutical Co., Ltd.

    CDMO
    China
    https://www.lifeonapi.com/

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    Drug Product
    Company Overview

    About

    Hefei Lifeon Pharmaceutical Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Gene Therapy, Cell Therapy, mRNA

    Therapeutic Areas

    Neurology
    Quick Facts
    HQ:China
    Founded:2014
    Employees:2,500
    Capabilities & Services

    Core Capabilities

    • Cytotoxic / ADC Handling
    • High-Potency API
    • Sterile Fill/Finish

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Topical / Transdermal

    Containment Capabilities

    OEB 5 (≤1 µg/m³)
    Cytotoxic / ADC Handling

    Production Scales

    Phase III Clinical Trials
    Commercial Scale
    Clinical

    Markets Served

    Asia-Pacific
    Manufacturing Facilities

    1 site worldwide

    Hefei Lifeon Pharmaceutical Co.,Ltd. (API branch)

    Tangkou Road and Qingluan Road Intersection, Economic and Technological Development Zone, Hefei, AnHui, 230000
    View on Map

    Site Capabilities

    1 capability
    API MANUFACTURE
    Regulatory Approvals
    Drug Approval 2KO90K
    PMDA · #APR-NOKU2PY2 · 2022-08-01
    Drug Approval LUV4HR
    PMDA · #APR-GC1QUHGI · 2021-11-01
    Certifications

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-B0V6FOGI
    Issued: 2020-01-22
    Expires: 2025-10-08

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-79D54R8W
    Issued: 2020-05-26
    Expires: 2025-05-09

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-CIBPDW5E
    Issued: 2020-10-22
    Expires: 2025-07-23
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    Key facts about Hefei Lifeon Pharmaceutical Co., Ltd.

    • Hefei Lifeon Pharmaceutical Co., Ltd. is headquartered in China.
    • Hefei Lifeon Pharmaceutical Co., Ltd. was founded in 2014.
    • Hefei Lifeon Pharmaceutical Co., Ltd. has 2,500 employees.
    • Hefei Lifeon Pharmaceutical Co., Ltd. has one manufacturing site listed on CDMO Hub, in Hefei, China.
    • Hefei Lifeon Pharmaceutical Co., Ltd.'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.

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    Directory pages this company appears in, each with the full list of matching manufacturers.

    CDMOs in ChinaCDMOs in AsiaFill-Finish CDMOsTopical / Transdermal CDMOsOEB 5 (≤1 µg/m³) CDMOsCytotoxic / ADC Handling CDMOs
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