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    Renejix Pharma Solutions

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

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    Drug Product
    Analytical & Bioanalytical Services
    Chemistry, Manufacturing and Controls
    Company Overview

    About

    Renejix Pharma Solutions is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Quality Control, Stability Testing, Method Development

    Therapeutic Areas

    Immunology
    Rheumatology
    Quick Facts
    HQ:United States
    Founded:2003
    Employees:2,035
    Capabilities & Services

    Core Capabilities

    • Peptide Synthesis
    • Small Molecule API
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Inhalation

    Containment Capabilities

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

    Production Scales

    Pilot Scale
    Clinical
    Commercial Scale

    Markets Served

    Asia-Pacific
    Regulatory Approvals
    Drug Approval DGXGHU
    Health Canada · #APR-19C1SA8I · 2020-05-01
    Drug Approval WTZ4FU
    Health Canada · #APR-72787NO6 · 2018-02-01

    Case Studies

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

    Certifications

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-R7C5LJRG
    Issued: 2020-10-22
    Expires: 2025-11-06

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-CY3T3JJA
    Issued: 2020-07-27
    Expires: 2025-02-21

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-NM3LIPLI
    Issued: 2020-01-21
    Expires: 2025-03-28
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    Key facts about Renejix Pharma Solutions

    • Renejix Pharma Solutions is headquartered in the United States.
    • Renejix Pharma Solutions was founded in 2003.
    • Renejix Pharma Solutions has 2,035 employees.
    • Renejix Pharma Solutions's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.

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    CDMOs in United StatesCDMOs in North AmericaSmall Molecule API CDMOsFormulation Development CDMOsInhalation CDMOsOEB 5 (≤1 µg/m³) CDMOsCytotoxic / ADC Handling CDMOs
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