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    Hangzhou Longshine Bio-Tech Co Ltd

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

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    Drug Product
    Company Overview

    About

    Hangzhou Longshine Bio-Tech Co Ltd is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization

    Therapeutic Areas

    Infectious Disease
    Quick Facts
    HQ:China
    Founded:2007
    Employees:1,607
    Capabilities & Services

    Core Capabilities

    • Small Molecule API
    • Small Molecule Drug Product
    • Oral Solid Dose

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Oral Solid Dose

    Containment Capabilities

    Cytotoxic / ADC Handling

    Production Scales

    Phase III Clinical Trials
    Commercial Scale
    Clinical

    Markets Served

    North America
    Regulatory Approvals
    Drug Approval HEI469
    EMA · #APR-JSFHAGLB · 2021-07-01
    Drug Approval X96D7F
    FDA · #APR-96MVF27S · 2021-09-01

    Case Studies

    0 published case studies showcasing past projects, challenges and outcomes.

    Certifications

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-57IPC2OK
    Issued: 2020-04-25
    Expires: 2025-06-11

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-TNVWL7RF
    Issued: 2020-02-06
    Expires: 2025-10-06
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    Key facts about Hangzhou Longshine Bio-Tech Co Ltd

    • Hangzhou Longshine Bio-Tech Co Ltd is headquartered in China.
    • Hangzhou Longshine Bio-Tech Co Ltd was founded in 2007.
    • Hangzhou Longshine Bio-Tech Co Ltd has 1,607 employees.
    • Hangzhou Longshine Bio-Tech Co Ltd's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.

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    CDMOs in ChinaCDMOs in AsiaSmall Molecule API CDMOsSmall Molecule Drug Product CDMOsOral Solid Dose CDMOsOral Solid Dose CDMOsCytotoxic / ADC Handling CDMOs
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