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    Rentschler Biopharma

    CDMO
    Germany
    https://www.rentschler-biopharma.com/

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

    About

    Rentschler Biopharma is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Gene Therapy, Cell Therapy, mRNA

    Therapeutic Areas

    Oncology
    Hematology
    Quick Facts
    HQ:Germany
    Founded:2003
    Employees:1,906
    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

    BSL-2 (Biosafety Level 2)

    Production Scales

    Pilot Scale
    Phase I Clinical Trials
    Clinical

    Markets Served

    Europe
    Manufacturing Facilities

    2 sites worldwide

    Rentschler Biopharma Inc.

    27 Maple Street, Milford, Massachusetts, 01757
    View on Map

    Site Capabilities

    2 capabilities
    ANALYSIS
    API MANUFACTURE

    Rentschler Biopharma SE

    Erwin-Rentschler Str. 21, Laupheim, Baden-Wuerttemberg D-, 88471
    View on Map

    Site Capabilities

    3 capabilities
    ANALYSIS
    API MANUFACTURE
    MANUFACTURE
    Regulatory Approvals
    Drug Approval DDVH4C
    FDA · #APR-EM5CHSEL · 2019-11-01

    Case Studies

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

    Certifications

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-BXHCJWXG
    Issued: 2020-06-17
    Expires: 2025-08-06

    Health Canada GMP

    Health Canada
    Cert #: CERT-1YZI26Z4
    Issued: 2020-11-16
    Expires: 2025-07-19
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    Key facts about Rentschler Biopharma

    • Rentschler Biopharma is headquartered in Germany.
    • Rentschler Biopharma was founded in 2003.
    • Rentschler Biopharma has 1,906 employees.
    • Rentschler Biopharma has 2 manufacturing sites listed on CDMO Hub, in Milford, United States and Laupheim, Germany.
    • Rentschler Biopharma's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.

    Find CDMOs like Rentschler Biopharma

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

    CDMOs in GermanyCDMOs in EuropeOral Solid Dose CDMOsFormulation Development CDMOsLyophilized (Freeze-Dried) CDMOsSterile Injectable CDMOsBSL-2 (Biosafety Level 2) CDMOs
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