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    Dynage Engineering GmbH

    CDMO
    Italy
    https://www.dynage.eu/

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

    About

    Dynage Engineering GmbH is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization

    Therapeutic Areas

    Oncology
    Hematology
    Quick Facts
    HQ:Italy
    Founded:2013
    Employees:2,484
    Capabilities & Services

    Core Capabilities

    • Oral Solid Dose
    • Solid Dose Manufacturing
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Lyophilized (Freeze-Dried)
    Sterile Injectable

    Containment Capabilities

    Cytotoxic / ADC Handling

    Production Scales

    Pilot Scale
    Phase I Clinical Trials
    Clinical

    Markets Served

    North America
    Regulatory Approvals
    Drug Approval YGKW3E
    PMDA · #APR-ZZLQQX7A · 2022-05-01

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-7OMGI5LI
    Issued: 2020-02-13
    Expires: 2025-01-20

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-W7SVZDM2
    Issued: 2020-03-25
    Expires: 2025-03-25

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-I9DV1S6C
    Issued: 2020-09-17
    Expires: 2025-08-25

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-U932XY2I
    Issued: 2020-02-22
    Expires: 2025-09-09
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    Key facts about Dynage Engineering GmbH

    • Dynage Engineering GmbH is headquartered in Italy.
    • Dynage Engineering GmbH was founded in 2013.
    • Dynage Engineering GmbH has 2,484 employees.
    • Dynage Engineering GmbH's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.

    Find CDMOs like Dynage Engineering GmbH

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

    CDMOs in ItalyCDMOs in EuropeOral Solid Dose CDMOsFormulation Development CDMOsLyophilized (Freeze-Dried) CDMOsSterile Injectable CDMOsCytotoxic / ADC Handling CDMOs
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