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    3. /STASON PHARMACEUTICALS, INC.

    STASON PHARMACEUTICALS, INC.

    Premium Partner
    CDMO
    United States
    https://www.stasonpharma.com/

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    Drug Product
    Regulatory, Tech Transfer & Support Services
    Company Overview

    About

    STASON PHARMACEUTICALS, INC. is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Formulation Development, Process Development, Scale-up

    Therapeutic Areas

    Oncology
    Hematology
    Quick Facts
    HQ:United States
    Founded:2009
    Employees:1,598
    Capabilities & Services

    Core Capabilities

    • Oral Solid Dose
    • Solid Dose Manufacturing
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Lyophilized (Freeze-Dried)
    Sterile Injectable

    Containment Capabilities

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

    Production Scales

    Pilot Scale
    Phase I Clinical Trials
    Clinical

    Markets Served

    Asia-Pacific
    Manufacturing Facilities

    1 site worldwide

    Stason Pharmaceuticals, Inc.

    11 Morgan, Irvine, California, 92618
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    Regulatory Approvals
    Drug Approval T8JOUR
    Health Canada · #APR-O2739XYI · 2022-07-01
    Drug Approval HYDLYH
    EMA · #APR-DXYBEFAG · 2021-02-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-HC07Y1XI
    Issued: 2020-08-01
    Expires: 2025-01-01

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-T7R6S6HV
    Issued: 2020-04-14
    Expires: 2025-03-03

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-EUZFSZO1
    Issued: 2020-07-14
    Expires: 2025-09-06
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    Key facts about STASON PHARMACEUTICALS, INC.

    • STASON PHARMACEUTICALS, INC. is headquartered in the United States.
    • STASON PHARMACEUTICALS, INC. was founded in 2009.
    • STASON PHARMACEUTICALS, INC. has 1,598 employees.
    • STASON PHARMACEUTICALS, INC. has one manufacturing site listed on CDMO Hub, in Irvine, United States.
    • STASON PHARMACEUTICALS, INC.'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.

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    CDMOs in United StatesCDMOs in North AmericaOral Solid Dose CDMOsFormulation Development CDMOsLyophilized (Freeze-Dried) CDMOsSterile Injectable CDMOsOEB 5 (≤1 µg/m³) CDMOsCytotoxic / ADC Handling CDMOs
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