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    CoastalPharma Inc.

    CDMO
    South Korea
    https://coastalpharmainc.com

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    Drug Product
    Chemistry, Manufacturing and Controls
    Qualification/Validation Services
    Regulatory, Tech Transfer & Support Services
    Company Overview

    About

    CoastalPharma Inc. is a leading contract development and manufacturing organization headquartered in South Korea. We specialize in Packaging, Small Molecule API Manufacturer with state-of-the-art facilities serving clients globally.

    Key Expertise

    Lyophilization, Fill/Finish (Vials), Regulatory Support, Formulation Development, Liquid/Semi-Solid

    Therapeutic Areas

    Cardiovascular
    Endocrinology
    Quick Facts
    HQ:South Korea
    Founded:2022
    Employees:4,631
    Capabilities & Services

    Core Capabilities

    • Sterile Injectable
    • Sterile Fill/Finish
    • Fill/Finish (Vials)

    Types of Organization

    Biologics Manufacturer
    Drug Product Manufacturer (finished dosage, fill-finish, packaging)

    Dosage Forms

    Cartridge / Pen

    Production Scales

    Commercial Scale
    Large Scale (Metric Ton+)

    Batch Sizes

    100L-1000L
    1000L-5000L
    5000L+
    10L-100L

    Markets Served

    North America
    Europe
    Manufacturing Facilities

    4 sites worldwide

    CoastalPharma Inc. - Headquarters

    145 Pharma Park, Seoul, Seoul, 57212
    View on Map
    126,718 sq ft
    Established 1992

    Site Capabilities

    5 capabilities
    mRNA Production
    Fill/Finish (Vials)
    Analytical Services
    Fill/Finish (Syringes)
    Method Development & Validation

    CoastalPharma Inc. - Dusseldorf Facility

    464 Pharma Park, Dusseldorf, Dusseldorf, 58939
    View on Map
    182,480 sq ft
    Established 1998

    Site Capabilities

    3 capabilities
    Liquid/Semi-Solid
    Regulatory Support
    Sterile Injectable

    CoastalPharma Inc. - Marseille Facility

    220 Pharma Park, Marseille, Marseille, 16090
    View on Map
    446,203 sq ft
    Established 2008

    Site Capabilities

    3 capabilities
    Stability Studies
    Liquid/Semi-Solid
    Biologics Drug Product

    CoastalPharma Inc. - Busan Facility

    249 Science Drive, Busan, Busan, 71142
    View on Map
    288,456 sq ft
    Established 2019

    Site Capabilities

    3 capabilities
    Small Molecule API
    Analytical Services
    Antibody-Drug Conjugates (ADC)
    Regulatory Approvals
    Drug Approval BTCBA8
    PMDA · #APR-R8SFV3OJ · 2019-11-01
    Product Portfolio

    Advanced Drug Product Service

    Brochure

    Our specialized service offering for Metabolic Disease and Dermatology applications.

    Injectable
    Lyophilized Powder
    Delivery: IV Infusion, Subcutaneous

    Premium Fill-Finish Service

    Brochure

    Our specialized service offering for Rare Disease and Oncology applications.

    Injectable
    Lyophilized Powder
    Capsule
    Tablet
    Delivery: Inhalation, IV Infusion, Subcutaneous

    Standard Formulation Service

    Brochure

    Our specialized service offering for Metabolic Disease applications.

    Suspension
    Capsule
    Cream
    Ointment
    Delivery: IV Infusion, Subcutaneous
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-SFUWRM54
    Issued: 2020-07-21
    Expires: 2025-07-23

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-E8E7D967
    Issued: 2020-07-25
    Expires: 2025-02-27

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-TDZLK5QJ
    Issued: 2020-05-17
    Expires: 2025-05-21

    Health Canada GMP

    Health Canada
    Cert #: CERT-2HO8YTZI
    Issued: 2020-08-07
    Expires: 2025-05-24
    Customer Reviews
    4.4

    Overall Rating(Based on 14 reviews)

    Project Management4.9
    Technology Transfer4.6
    On-Time Delivery4.9
    Communication Responsiveness4.5
    Innovation3.2
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    Key facts about CoastalPharma Inc.

    • CoastalPharma Inc. is headquartered in South Korea.
    • CoastalPharma Inc. was founded in 2022.
    • CoastalPharma Inc. has 4,631 employees.
    • CoastalPharma Inc. has 4 manufacturing sites listed on CDMO Hub, in Seoul, South Korea, Dusseldorf, Germany, Marseille, France and Busan, South Korea.
    • CoastalPharma Inc.'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).

    Find CDMOs like CoastalPharma Inc.

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

    CDMOs in South KoreaCDMOs in AsiaSterile Injectable CDMOsFill-Finish CDMOsFill/Finish (Vials) CDMOsCartridge / Pen CDMOs
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