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    Stearinerie Dubois Fils

    CDMO
    France
    https://www.stearinerie-dubois.com/

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    Excipients & Specialty Ingredients
    Company Overview

    About

    Stearinerie Dubois Fils is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Formulation Development, Process Development, Scale-up

    Therapeutic Areas

    Rare Disease
    Metabolic
    Quick Facts
    HQ:France
    Founded:1994
    Employees:2,951
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Drug Product
    • Biologics Manufacturing

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Prefilled Syringe
    Sterile Injectable

    Containment Capabilities

    BSL-2 (Biosafety Level 2)

    Production Scales

    Phase III Clinical Trials
    Commercial Scale
    Clinical

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval FOOLY8
    Health Canada · #APR-EE63LWZR · 2021-05-01
    Drug Approval LGLOAJ
    Health Canada · #APR-UIRW1MHS · 2018-11-01

    Case Studies

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

    Certifications

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-X2UZXU1G
    Issued: 2020-03-12
    Expires: 2025-10-26

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-0SLCKSU7
    Issued: 2020-04-12
    Expires: 2025-03-01

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-EMDTOZR9
    Issued: 2020-11-08
    Expires: 2025-06-04

    WHO GMP

    World Health Organization
    Cert #: CERT-PTZP6L52
    Issued: 2020-08-12
    Expires: 2025-02-28
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    Key facts about Stearinerie Dubois Fils

    • Stearinerie Dubois Fils is headquartered in France.
    • Stearinerie Dubois Fils was founded in 1994.
    • Stearinerie Dubois Fils has 2,951 employees.
    • Stearinerie Dubois Fils's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.

    Find CDMOs like Stearinerie Dubois Fils

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    CDMOs in FranceCDMOs in EuropeBiologics Drug Substance CDMOsBiologics Drug Product CDMOsPrefilled Syringe CDMOsSterile Injectable CDMOsBSL-2 (Biosafety Level 2) CDMOs
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