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    Lotte Fine Chemical Co., Ltd.

    CDMO
    South Korea
    https://www.lottefinechem.com/

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    Excipients & Specialty Ingredients
    Company Overview

    About

    Lotte Fine Chemical Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization

    Therapeutic Areas

    Oncology
    Hematology
    Quick Facts
    HQ:South Korea
    Founded:2018
    Employees:444
    Capabilities & Services

    Core Capabilities

    • Oral Solid Dose
    • Solid Dose Manufacturing
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Lyophilized (Freeze-Dried)
    Sterile Injectable

    Containment Capabilities

    OEB 4 (1-10 µg/m³)

    Production Scales

    Phase II
    Clinical
    Pilot Scale

    Markets Served

    Global
    Regulatory Approvals
    Drug Approval KRGTR1
    Health Canada · #APR-WNQHYBV9 · 2019-04-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-V226O2FK
    Issued: 2020-10-07
    Expires: 2025-05-28

    Health Canada GMP

    Health Canada
    Cert #: CERT-JVP7QXCH
    Issued: 2020-07-03
    Expires: 2025-05-22
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    Key facts about Lotte Fine Chemical Co., Ltd.

    • Lotte Fine Chemical Co., Ltd. is headquartered in South Korea.
    • Lotte Fine Chemical Co., Ltd. was founded in 2018.
    • Lotte Fine Chemical Co., Ltd. has 444 employees.
    • Lotte Fine Chemical Co., Ltd.'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.

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

    CDMOs in South KoreaCDMOs in AsiaOral Solid Dose CDMOsFormulation Development CDMOsLyophilized (Freeze-Dried) CDMOsSterile Injectable CDMOsOEB 4 (1-10 µg/m³) CDMOs
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