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    MK Versuchsanlagen GmbH & Co. KG logo

    MK Versuchsanlagen GmbH & Co. KG

    CDMO
    Germany
    https://www.mk-versuchsanlagen.de/

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    Manufacturing & Lab Equipment
    Regulatory, Tech Transfer & Support Services
    Company Overview

    About

    MK Versuchsanlagen GmbH & Co. KG is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Quality Control, Stability Testing, Method Development

    Therapeutic Areas

    Rare Disease
    Metabolic
    Quick Facts
    HQ:Germany
    Founded:1991
    Employees:2,507
    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

    OEB 4 (1-10 µg/m³)

    Production Scales

    R&D / Pre-clinical
    Lab Scale
    Pilot Scale

    Markets Served

    Global
    Regulatory Approvals
    Drug Approval 4YC06K
    EMA · #APR-4VSLNAA9 · 2018-06-01
    Drug Approval GI7NBN
    FDA · #APR-GQ6P2P3Y · 2019-02-01

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-4USALWDD
    Issued: 2020-09-17
    Expires: 2025-12-15

    WHO GMP

    World Health Organization
    Cert #: CERT-ACSA46SK
    Issued: 2020-07-02
    Expires: 2025-10-21

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-QK4UC15E
    Issued: 2020-06-01
    Expires: 2025-10-01
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    Key facts about MK Versuchsanlagen GmbH & Co. KG

    • MK Versuchsanlagen GmbH & Co. KG is headquartered in Germany.
    • MK Versuchsanlagen GmbH & Co. KG was founded in 1991.
    • MK Versuchsanlagen GmbH & Co. KG has 2,507 employees.
    • MK Versuchsanlagen GmbH & Co. KG's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.

    Find CDMOs like MK Versuchsanlagen GmbH & Co. KG

    Directory pages this company appears in, each with the full list of matching manufacturers.

    CDMOs in GermanyCDMOs in EuropeBiologics Drug Substance CDMOsBiologics Drug Product CDMOsPrefilled Syringe CDMOsSterile Injectable CDMOsOEB 4 (1-10 µg/m³) CDMOs
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