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    3. /Esteve CDMO (Esteve Química)
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    Esteve CDMO (Esteve Química)

    CDMO
    Spain
    https://www.esteve.com/global/contract-manufacturing

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    Drug Product
    Analytical & Bioanalytical Services
    Company Overview

    About

    Esteve CDMO (Esteve Química) is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Formulation Development, Process Development, Scale-up

    Therapeutic Areas

    Immunology
    Rheumatology
    Quick Facts
    HQ:Spain
    Founded:2016
    Employees:2,613
    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
    Phase I Clinical Trials
    Clinical

    Markets Served

    Asia-Pacific
    Regulatory Approvals
    Drug Approval QDVXBB
    FDA · #APR-AJCC9I9E · 2018-06-01
    Drug Approval VKKDTA
    Health Canada · #APR-LUVUX10Z · 2022-09-01

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-YGFMPNVB
    Issued: 2020-05-14
    Expires: 2025-04-26

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-T8FQIBYP
    Issued: 2020-10-01
    Expires: 2025-01-25
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    Key facts about Esteve CDMO (Esteve Química)

    • Esteve CDMO (Esteve Química) is headquartered in Spain.
    • Esteve CDMO (Esteve Química) was founded in 2016.
    • Esteve CDMO (Esteve Química) has 2,613 employees.
    • Esteve CDMO (Esteve Química)'s capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.

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    CDMOs in SpainCDMOs in EuropeSmall Molecule API CDMOsFormulation Development CDMOsInhalation CDMOsOEB 5 (≤1 µg/m³) CDMOsCytotoxic / ADC Handling CDMOs
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