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    SummitPharma Inc.

    CDMO
    Japan
    https://summitpharmainc.com

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    Drug Product
    Advanced Modalities
    Contract Research Organization
    Company Overview

    About

    SummitPharma Inc. is a leading contract development and manufacturing organization headquartered in Japan. We specialize in Cell & Gene Therapy, Clinical Trial Materials with state-of-the-art facilities serving clients globally.

    Key Expertise

    mRNA Production, Oral Solid Dose, Viral Vectors, Microbiology Testing, Fill/Finish (Cartridges)

    Therapeutic Areas

    Oncology
    Hematology
    Quick Facts
    HQ:Japan
    Founded:2000
    Employees:14,106
    Capabilities & Services

    Core Capabilities

    • Oral Solid Dose
    • Solid Dose Manufacturing
    • Formulation Development

    Types of Organization

    Advanced Therapy Manufacturer (cell, gene, mRNA, ADC)
    Biologics Manufacturer
    Clinical Trial Supply & Logistics Provider
    Contract Research Organization (CRO)
    Drug Substance / API Manufacturer

    Dosage Forms

    Lyophilized (Freeze-Dried)
    Sterile Injectable

    Containment Capabilities

    Cytotoxic / ADC Handling

    Production Scales

    Commercial Scale
    Large Scale (Metric Ton+)

    Batch Sizes

    5000L+
    10L-100L

    Markets Served

    North America
    Manufacturing Facilities

    4 sites worldwide

    SummitPharma Inc. - Headquarters

    281 Industrial Boulevard, Tokyo, Tokyo, 80092
    View on Map
    356,943 sq ft
    Established 2004

    Site Capabilities

    4 capabilities
    Stability Studies
    Regulatory Support
    Fill/Finish (Cartridges)
    Viral Vectors

    SummitPharma Inc. - Nagoya Facility

    500 Pharma Park, Nagoya, Nagoya, 23643
    View on Map
    263,959 sq ft
    Established 1999

    Site Capabilities

    4 capabilities
    Small Molecule API
    mRNA Production
    Fill/Finish (Cartridges)
    Aseptic Processing

    SummitPharma Inc. - Tokyo Facility

    542 Industrial Park, Tokyo, Tokyo, 22135
    View on Map
    236,200 sq ft
    Established 2020

    Site Capabilities

    4 capabilities
    Small Molecule API
    Fill/Finish (Cartridges)
    Cell & Gene Therapy
    mRNA Production

    SummitPharma Inc. - Kobe Facility

    671 Science Park, Kobe, Kobe, 22597
    View on Map
    294,897 sq ft
    Established 2010

    Site Capabilities

    4 capabilities
    Small Molecule API
    Antibody-Drug Conjugates (ADC)
    Stability Studies
    Liquid/Semi-Solid
    Regulatory Approvals
    Drug Approval J8XXSL
    PMDA · #APR-WEG4FDFL · 2018-06-01
    Product Portfolio

    Advanced Fill-Finish Service

    Brochure

    Our specialized service offering for Dermatology and Immunology applications.

    Capsule
    Lyophilized Powder
    Delivery: IV Infusion, Subcutaneous, Intramuscular

    Standard Drug Product Service

    Brochure

    Our flagship service offering for Rare Disease and Ophthalmology applications.

    Tablet
    Capsule
    Delivery: IV Infusion, Subcutaneous, Intramuscular

    Premium Fill-Finish Service

    Brochure

    Our flagship service offering for Dermatology applications.

    Lyophilized Powder
    Injectable
    Delivery: Subcutaneous, Topical

    Advanced Formulation Service

    Brochure

    Our specialized service offering for Oncology and Rare Disease applications.

    Tablet
    Lyophilized Powder
    Solution
    Delivery: Intramuscular, Subcutaneous, IV Infusion

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-0X37HD0J
    Issued: 2020-01-16
    Expires: 2025-07-14

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-PHYOQA11
    Issued: 2020-11-18
    Expires: 2025-11-03
    Customer Reviews
    4.2

    Overall Rating(Based on 3 reviews)

    Project Management4.6
    Technology Transfer4.0
    On-Time Delivery3.4
    Communication Responsiveness4.3
    Innovation4.6
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    Key facts about SummitPharma Inc.

    • SummitPharma Inc. is headquartered in Japan.
    • SummitPharma Inc. was founded in 2000.
    • SummitPharma Inc. has 14,106 employees.
    • SummitPharma Inc. has 4 manufacturing sites listed on CDMO Hub, in Tokyo, Japan, Nagoya, Japan and Kobe, Japan.
    • SummitPharma Inc.'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.

    Find CDMOs like SummitPharma Inc.

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

    CDMOs in JapanCDMOs in AsiaOral Solid Dose CDMOsFormulation Development CDMOsLyophilized (Freeze-Dried) CDMOsSterile Injectable CDMOsCytotoxic / ADC Handling CDMOs
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