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    PEKU Folien

    CDMO
    Germany
    https://www.peku-folien.de/

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    Drug Product
    Company Overview

    About

    PEKU Folien is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Quality Control, Stability Testing, Method Development

    Therapeutic Areas

    Oncology
    Hematology
    Quick Facts
    HQ:Germany
    Founded:2008
    Employees:955
    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

    Phase II
    Clinical
    Pilot Scale

    Markets Served

    North America
    Regulatory Approvals
    Drug Approval 1MI56U
    FDA · #APR-1HDN972C · 2018-03-01
    Drug Approval ZNPWIV
    PMDA · #APR-4WHUGQ0L · 2022-02-01
    Certifications

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-SRVHN8PO
    Issued: 2020-10-08
    Expires: 2025-08-24

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-CLSVEW7I
    Issued: 2020-12-10
    Expires: 2025-11-16

    Health Canada GMP

    Health Canada
    Cert #: CERT-9GW1HUIA
    Issued: 2020-06-25
    Expires: 2025-04-03
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    Key facts about PEKU Folien

    • PEKU Folien is headquartered in Germany.
    • PEKU Folien was founded in 2008.
    • PEKU Folien has 955 employees.
    • PEKU Folien's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.

    Find CDMOs like PEKU Folien

    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 CDMOsCytotoxic / ADC Handling CDMOs
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