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    Bionex Pharmaceuticals (USA)

    CDMO
    United States
    https://www.bionexpharma.com/

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    Drug Product
    Analytical & Bioanalytical Services
    Regulatory, Tech Transfer & Support Services
    Company Overview

    About

    Bionex Pharmaceuticals (USA) is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals

    Therapeutic Areas

    Respiratory
    Allergy
    Quick Facts
    HQ:United States
    Founded:1998
    Employees:194
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Manufacturing
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Sterile Injectable

    Containment Capabilities

    BSL-2 (Biosafety Level 2)

    Production Scales

    Commercial Scale
    Large Scale (Metric Ton+)

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval 6DY933
    PMDA · #APR-AWKULF9K · 2022-02-01
    Drug Approval 0INSM8
    FDA · #APR-ZMQ3S2Y4 · 2019-02-01
    Certifications

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-KUK6LIZJ
    Issued: 2020-11-06
    Expires: 2025-07-03

    Health Canada GMP

    Health Canada
    Cert #: CERT-D7WR1TYX
    Issued: 2020-04-02
    Expires: 2025-07-06
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    Key facts about Bionex Pharmaceuticals (USA)

    • Bionex Pharmaceuticals (USA) is headquartered in the United States.
    • Bionex Pharmaceuticals (USA) was founded in 1998.
    • Bionex Pharmaceuticals (USA) has 194 employees.
    • Bionex Pharmaceuticals (USA)'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

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    CDMOs in United StatesCDMOs in North AmericaBiologics Drug Substance CDMOsFormulation Development CDMOsSterile Injectable CDMOsBSL-2 (Biosafety Level 2) CDMOs
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