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    Kalbe (Kalbe Farma)

    CDMO
    Indonesia
    https://www.kalbe.co.id/

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    Drug Product
    Company Overview

    About

    Kalbe (Kalbe Farma) is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Formulation Development, Process Development, Scale-up

    Therapeutic Areas

    Immunology
    Rheumatology
    Quick Facts
    HQ:Indonesia
    Founded:2017
    Employees:708
    Capabilities & Services

    Core Capabilities

    • Peptide Synthesis
    • Small Molecule API
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Inhalation

    Containment Capabilities

    BSL-2 (Biosafety Level 2)

    Production Scales

    Phase III Clinical Trials
    Commercial Scale
    Clinical

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval 54XXFX
    EMA · #APR-YG13ANH3 · 2018-09-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-OZOB394M
    Issued: 2020-09-09
    Expires: 2025-01-25

    Health Canada GMP

    Health Canada
    Cert #: CERT-3PAKQ4VQ
    Issued: 2020-11-20
    Expires: 2025-01-28
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    Key facts about Kalbe (Kalbe Farma)

    • Kalbe (Kalbe Farma) is headquartered in Indonesia.
    • Kalbe (Kalbe Farma) was founded in 2017.
    • Kalbe (Kalbe Farma) has 708 employees.
    • Kalbe (Kalbe Farma)'s capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.

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    Small Molecule API CDMOsFormulation Development CDMOsInhalation CDMOsBSL-2 (Biosafety Level 2) CDMOs
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