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    Bacthera

    CDMO
    Denmark
    https://www.bacthera.com/

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    Advanced Modalities
    Drug Product
    Analytical & Bioanalytical Services
    Regulatory, Tech Transfer & Support Services
    Company Overview

    About

    Bacthera is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Formulation Development, Process Development, Scale-up

    Therapeutic Areas

    Infectious Disease
    Quick Facts
    HQ:Denmark
    Founded:1992
    Employees:2,088
    Capabilities & Services

    Core Capabilities

    • Small Molecule API
    • Small Molecule Drug Product
    • Oral Solid Dose

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Oral Solid Dose

    Containment Capabilities

    Cytotoxic / ADC Handling

    Production Scales

    Phase III Clinical Trials
    Commercial Scale
    Clinical

    Markets Served

    North America
    International Regulatory
    EU GMP Certificates
    2
    Regulatory Bodies
    EMA/EudraGMDP
    Regulatory Approvals
    Drug Approval EYD6VL
    PMDA · #APR-K8Z598A3 · 2019-02-01
    Drug Approval CFQUWE
    EMA · #APR-AVTH7RBB · 2022-11-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-ZJ0THWAH
    Issued: 2020-01-19
    Expires: 2025-08-20

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-ZTAIV3AT
    Issued: 2020-01-26
    Expires: 2025-03-21

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-H1XWK5UF
    Issued: 2020-01-28
    Expires: 2025-11-13
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    Key facts about Bacthera

    • Bacthera is headquartered in Denmark.
    • Bacthera was founded in 1992.
    • Bacthera has 2,088 employees.
    • Bacthera's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.

    Find CDMOs like Bacthera

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

    CDMOs in DenmarkCDMOs in EuropeSmall Molecule API CDMOsSmall Molecule Drug Product CDMOsOral Solid Dose CDMOsOral Solid Dose CDMOsCytotoxic / ADC Handling CDMOs
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