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    Nira Life Sciences Pvt Ltd logo

    Nira Life Sciences Pvt Ltd

    CDMO
    India
    https://www.niralifesciences.com/

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    Drug Product
    Company Overview

    About

    Nira Life Sciences Pvt Ltd 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:2005
    Employees:199
    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

    OEB 4 (1-10 µg/m³)

    Production Scales

    R&D / Pre-clinical
    Lab Scale
    Pilot Scale

    Markets Served

    Global
    Regulatory Approvals
    Drug Approval QAW5GW
    Health Canada · #APR-OUZ1DLMW · 2019-11-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-CF1620JL
    Issued: 2020-04-06
    Expires: 2025-10-13

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-LAD2AN5J
    Issued: 2020-06-18
    Expires: 2025-08-08

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-AU4NCV4B
    Issued: 2020-10-17
    Expires: 2025-02-11
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    Key facts about Nira Life Sciences Pvt Ltd

    • Nira Life Sciences Pvt Ltd is headquartered in India.
    • Nira Life Sciences Pvt Ltd was founded in 2005.
    • Nira Life Sciences Pvt Ltd has 199 employees.
    • Nira Life Sciences Pvt Ltd'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 CDMOsOEB 4 (1-10 µg/m³) CDMOs
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