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    3. /Novinox S.r.l.
    Novinox S.r.l. logo

    Novinox S.r.l.

    CDMO
    Italy
    https://www.novinox.com/en/

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    Manufacturing & Lab Equipment
    Company Overview

    About

    Novinox S.r.l. is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Quality Control, Stability Testing, Method Development

    Therapeutic Areas

    Respiratory
    Allergy
    Quick Facts
    HQ:Italy
    Founded:2002
    Employees:3,093
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Manufacturing
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Sterile Injectable

    Containment Capabilities

    BSL-2 (Biosafety Level 2)

    Production Scales

    Commercial Scale
    Large Scale (Metric Ton+)

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval GW59XG
    EMA · #APR-GWIIDFI0 · 2022-04-01

    Case Studies

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

    Certifications

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-XXO7OFEQ
    Issued: 2020-09-27
    Expires: 2025-01-19

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-2TRZM19P
    Issued: 2020-08-06
    Expires: 2025-07-14

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-563E0K9T
    Issued: 2020-06-13
    Expires: 2025-05-11

    Health Canada GMP

    Health Canada
    Cert #: CERT-U3VLE6UJ
    Issued: 2020-07-25
    Expires: 2025-07-12
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    Key facts about Novinox S.r.l.

    • Novinox S.r.l. is headquartered in Italy.
    • Novinox S.r.l. was founded in 2002.
    • Novinox S.r.l. has 3,093 employees.
    • Novinox S.r.l.'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 CDMOsBSL-2 (Biosafety Level 2) CDMOs
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