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    NovaTherapeutics Ltd.

    CDMO
    Austria
    https://novatherapeuticsltd.com

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    Analytical & Bioanalytical Services
    Manufacturing & Lab Equipment
    Regulatory, Tech Transfer & Support Services
    Company Overview

    About

    NovaTherapeutics Ltd. is a leading contract development and manufacturing organization headquartered in Austria. We specialize in Cell & Gene Therapy, Packaging with state-of-the-art facilities serving clients globally.

    Key Expertise

    Fill/Finish (Vials), Aseptic Processing, Small Molecule API, Small Molecule Drug Product, Biologics Drug Substance

    Therapeutic Areas

    Rare Disease
    Metabolic
    Quick Facts
    HQ:Austria
    Founded:2007
    Employees:535
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Drug Product
    • Biologics Manufacturing

    Types of Organization

    Advanced Therapy Manufacturer (cell, gene, mRNA, ADC)
    Analytical & Bioanalytical Laboratory
    Biologics Manufacturer
    Drug Product Manufacturer (finished dosage, fill-finish, packaging)
    Formulation Development

    Dosage Forms

    Prefilled Syringe
    Sterile Injectable

    Production Scales

    R&D / Pre-clinical
    Lab Scale
    Pilot Scale

    Batch Sizes

    100L-1000L
    10L-100L

    Markets Served

    North America
    Europe
    Manufacturing Facilities

    1 site worldwide

    NovaTherapeutics Ltd. - Headquarters

    967 Industrial Way, Salzburg, Salzburg, 26921
    View on Map
    238,637 sq ft
    Established 2001

    Site Capabilities

    6 capabilities
    Regulatory Support
    Viral Vectors
    Supply Chain Management
    Lyophilization
    Biologics Drug Product
    Formulation Development
    Regulatory Approvals
    Drug Approval GRBOYU
    Health Canada · #APR-06KXJ7JT · 2021-03-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-NI5C2U8K
    Issued: 2020-01-01
    Expires: 2025-11-11

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-RKGSXW1R
    Issued: 2020-04-28
    Expires: 2025-09-02

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-KL34FNF0
    Issued: 2020-09-11
    Expires: 2025-06-27
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    Key facts about NovaTherapeutics Ltd.

    • NovaTherapeutics Ltd. is headquartered in Austria.
    • NovaTherapeutics Ltd. was founded in 2007.
    • NovaTherapeutics Ltd. has 535 employees.
    • NovaTherapeutics Ltd. has one manufacturing site listed on CDMO Hub, in Salzburg, Austria.
    • NovaTherapeutics Ltd.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.

    Find CDMOs like NovaTherapeutics Ltd.

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

    Biologics Drug Substance CDMOsBiologics Drug Product CDMOsPrefilled Syringe CDMOsSterile Injectable CDMOs
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