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    TekniPlex (TekniPlex Healthcare)

    Premium Partner
    CDMO
    Italy
    https://tekni-plex.com/en/healthcare/

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    Drug Product
    Manufacturing & Lab Equipment
    Company Overview

    About

    TekniPlex (TekniPlex Healthcare) is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization

    Therapeutic Areas

    Respiratory
    Allergy
    Quick Facts
    HQ:Italy
    Founded:1990
    Employees:676
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Manufacturing
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Sterile Injectable

    Production Scales

    R&D / Pre-clinical
    Lab Scale
    Pilot Scale

    Markets Served

    North America
    Europe
    Regulatory Approvals
    Drug Approval B518TZ
    Health Canada · #APR-STZ9B970 · 2019-04-01

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-UEGT7TEY
    Issued: 2020-10-08
    Expires: 2025-02-12

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-W4PCE9H8
    Issued: 2020-10-25
    Expires: 2025-11-03

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-6R0UHCSX
    Issued: 2020-07-11
    Expires: 2025-02-19

    WHO GMP

    World Health Organization
    Cert #: CERT-WSL8J6US
    Issued: 2020-07-21
    Expires: 2025-12-05
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    Key facts about TekniPlex (TekniPlex Healthcare)

    • TekniPlex (TekniPlex Healthcare) is headquartered in Italy.
    • TekniPlex (TekniPlex Healthcare) was founded in 1990.
    • TekniPlex (TekniPlex Healthcare) has 676 employees.
    • TekniPlex (TekniPlex Healthcare)'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

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    CDMOs in ItalyCDMOs in EuropeBiologics Drug Substance CDMOsFormulation Development CDMOsSterile Injectable CDMOs
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