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    3. /Caplin Point Laboratories / Caplin Steriles

    Caplin Point Laboratories / Caplin Steriles

    Premium Partner
    CDMO
    India
    https://www.caplinpoint.net/

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    Drug Product
    Company Overview

    About

    Caplin Point Laboratories / Caplin Steriles is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines

    Therapeutic Areas

    Respiratory
    Allergy
    Quick Facts
    HQ:India
    Founded:2017
    Employees:991
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Manufacturing
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Sterile Injectable

    Containment Capabilities

    BSL-2 (Biosafety Level 2)

    Production Scales

    Phase II
    Clinical
    Pilot Scale

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval KJ97RW
    PMDA · #APR-4YQ9O4EH · 2022-01-01

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-WL7S5KQ1
    Issued: 2020-11-13
    Expires: 2025-11-15

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-3B66WPVH
    Issued: 2020-07-02
    Expires: 2025-11-10

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-MSW9HJ9P
    Issued: 2020-06-18
    Expires: 2025-09-25

    WHO GMP

    World Health Organization
    Cert #: CERT-LZJGOR6C
    Issued: 2020-02-23
    Expires: 2025-10-25
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    Key facts about Caplin Point Laboratories / Caplin Steriles

    • Caplin Point Laboratories / Caplin Steriles is headquartered in India.
    • Caplin Point Laboratories / Caplin Steriles was founded in 2017.
    • Caplin Point Laboratories / Caplin Steriles has 991 employees.
    • Caplin Point Laboratories / Caplin Steriles's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

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    CDMOs in IndiaCDMOs in AsiaBiologics Drug Substance CDMOsFormulation Development CDMOsSterile Injectable CDMOsBSL-2 (Biosafety Level 2) CDMOs
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