CDMOHUBCDMOHUB
Pricing
    CDMOHUBCDMOHUB
    Pricing
    CDMOHUBCDMOHUB
    Pricing
    CDMOHUBCDMOHUB
    Pricing
    1. Home
    2. /CDMOs
    3. /StrategicPharma GmbH

    StrategicPharma GmbH

    CDMO
    Norway
    https://strategicpharmagmbh.com

    Is this your company? Claim this profile

    Clinical Trial Supply & Logistics
    Manufacturing & Lab Equipment
    Company Overview

    About

    StrategicPharma GmbH is a leading contract development and manufacturing organization headquartered in Norway. We specialize in Commercial Manufacturing, Fill/Finish with state-of-the-art facilities serving clients globally.

    Key Expertise

    Antibody-Drug Conjugates (ADC), Small Molecule API, Lyophilization, Cell & Gene Therapy, Biologics Drug Product

    Therapeutic Areas

    Rare Disease
    Metabolic
    Quick Facts
    HQ:Norway
    Founded:2018
    Employees:2,434
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Drug Product
    • Biologics Manufacturing

    Types of Organization

    Drug Substance / API Manufacturer
    Formulation Development

    Dosage Forms

    Prefilled Syringe
    Sterile Injectable

    Containment Capabilities

    Cytotoxic / ADC Handling

    Production Scales

    Pilot Scale
    Clinical
    Commercial Scale

    Batch Sizes

    100L-1000L
    5000L+

    Markets Served

    North America
    Manufacturing Facilities

    4 sites worldwide

    StrategicPharma GmbH - Headquarters

    289 Technology Way, Oslo, Oslo, 35955
    View on Map
    53,048 sq ft
    Established 1992

    Site Capabilities

    5 capabilities
    Packaging & Labeling
    Regulatory Support
    Liquid/Semi-Solid
    Formulation Development
    Fill/Finish (Cartridges)

    StrategicPharma GmbH - Paris Facility

    408 Industrial Way, Paris, Paris, 27676
    View on Map
    62,355 sq ft
    Established 2009

    Site Capabilities

    3 capabilities
    Biologics Drug Substance
    Small Molecule Drug Product
    Stability Studies

    StrategicPharma GmbH - Oslo Facility

    846 Technology Boulevard, Oslo, Oslo, 66847
    View on Map
    283,822 sq ft
    Established 2003

    Site Capabilities

    7 capabilities
    Formulation Development
    Viral Vectors
    Supply Chain Management
    Antibody-Drug Conjugates (ADC)
    Analytical Services
    Method Development & Validation

    StrategicPharma GmbH - Oslo Facility

    132 Industrial Way, Oslo, Oslo, 15958
    View on Map
    297,615 sq ft
    Established 1999

    Site Capabilities

    8 capabilities
    Biologics Drug Product
    Lyophilization
    mRNA Production
    Oral Solid Dose
    Antibody-Drug Conjugates (ADC)
    Cell & Gene Therapy
    Regulatory Approvals
    Drug Approval 76PH8N
    Health Canada · #APR-KBWQX2M4 · 2022-10-01
    Drug Approval KJU1GZ
    Health Canada · #APR-8JHIWPTH · 2021-01-01
    Product Portfolio

    Standard Drug Product Service

    Brochure

    Our comprehensive service offering for Immunology applications.

    Ointment
    Tablet
    Suspension
    Lyophilized Powder
    Delivery: IV Infusion, Subcutaneous

    Premium Fill-Finish Service

    Brochure

    Our specialized service offering for Immunology applications.

    Tablet
    Capsule
    Suspension
    Injectable
    Delivery: Topical, Oral

    Case Studies

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

    Oncology Monoclonal Antibody Development Partnership

    Phase I
    mRNA
    Aug 2020 – Sep 2023
    317 views

    Successful Phase I manufacturing program for a leading biotech client.

    Challenge

    The client required rapid scale-up of their Oncology therapeutic with aggressive timelines and complex analytical requirements.

    Solution

    We deployed our experienced team and state-of-the-art facilities to develop a robust manufacturing process. Key innovations included process intensification and real-time analytics.

    Outcome

    The program achieved all milestones on schedule. The product received regulatory approval and is now in commercial production.

    Oncology
    Dermatology
    Download PDF

    Metabolic Disease Cell Therapy Development Partnership

    Pre-approval / BLA/NDA
    Gene Therapy
    Cell Therapy
    Feb 2022 – Feb 2022
    259 views

    Successful Pre-approval / BLA/NDA manufacturing program for a virtual pharma client.

    Challenge

    The client required rapid scale-up of their Metabolic Disease therapeutic with aggressive timelines and complex analytical requirements.

    Solution

    We deployed our experienced team and state-of-the-art facilities to develop a robust manufacturing process. Key innovations included process intensification and real-time analytics.

    Outcome

    The program achieved all milestones on schedule. The product received regulatory approval and is now in commercial production.

    Metabolic Disease
    Download PDF
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-EGEURCF1
    Issued: 2020-02-11
    Expires: 2025-01-03

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-HNXHM56P
    Issued: 2020-07-02
    Expires: 2025-04-10

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-U85QML7L
    Issued: 2020-02-06
    Expires: 2025-02-22
    Customer Reviews
    4.1

    Overall Rating(Based on 24 reviews)

    Project Management4.6
    Technology Transfer4.0
    On-Time Delivery3.4
    Communication Responsiveness3.7
    Innovation4.8
    Loading CDMO intelligence...
    Request an Introduction

    Please log in to contact this provider.

    Key facts about StrategicPharma GmbH

    • StrategicPharma GmbH is headquartered in Norway.
    • StrategicPharma GmbH was founded in 2018.
    • StrategicPharma GmbH has 2,434 employees.
    • StrategicPharma GmbH has 4 manufacturing sites listed on CDMO Hub, in Oslo, Norway and Paris, France.
    • StrategicPharma GmbH's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.

    Find CDMOs like StrategicPharma GmbH

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

    Biologics Drug Substance CDMOsBiologics Drug Product CDMOsPrefilled Syringe CDMOsSterile Injectable CDMOsCytotoxic / ADC Handling CDMOs
    CDMOHUB

    Connecting biotech and pharma teams with contract manufacturing partners worldwide.

    Platform

    • Find CDMOs
    • CDMO Matchmaking
    • Expert Matchmaking
    • SmartRFI
      Members
    • Modality Guides
    • Supplier Maps
    • Join as Partner

    Company

    • Blog
    • Briefings
    • About Us
    • Contact

    Legal

    • Terms of Service
    • Privacy Policy

    © 2026 CDMOHUB. All rights reserved.

    CDMO Hub, Inc. Registered in Delaware, USA