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    3. /Standard Chem. & Pharm. Co., Ltd.

    Standard Chem. & Pharm. Co., Ltd.

    Premium Partner
    CDMO
    Taiwan
    https://www.scp.com.tw/

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    Drug Product
    Company Overview

    About

    Standard Chem. & Pharm. Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Quality Control, Stability Testing, Method Development

    Therapeutic Areas

    Neurology
    Quick Facts
    HQ:Taiwan
    Founded:1991
    Employees:316
    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

    BSL-2 (Biosafety Level 2)

    Production Scales

    Commercial Scale
    Large Scale (Metric Ton+)

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval YBOXGO
    Health Canada · #APR-IWC97FBJ · 2019-08-01
    Drug Approval 3JLGE0
    EMA · #APR-QA7UHYP6 · 2020-05-01

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-5393XT4V
    Issued: 2020-05-15
    Expires: 2025-08-25

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-O9OVHGWC
    Issued: 2020-06-23
    Expires: 2025-12-17

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-OD06KJ4H
    Issued: 2020-01-24
    Expires: 2025-08-06
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    Key facts about Standard Chem. & Pharm. Co., Ltd.

    • Standard Chem. & Pharm. Co., Ltd. is headquartered in Taiwan.
    • Standard Chem. & Pharm. Co., Ltd. was founded in 1991.
    • Standard Chem. & Pharm. Co., Ltd. has 316 employees.
    • Standard Chem. & Pharm. Co., Ltd.'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.

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    Fill-Finish CDMOsTopical / Transdermal CDMOsBSL-2 (Biosafety Level 2) CDMOs
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