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    Newland Pharmaceutical Co. Ltd

    Premium Partner
    CDMO
    China
    http://www.newlandpharma.com/

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    Drug Product
    Company Overview

    About

    Newland Pharmaceutical Co. Ltd is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Gene Therapy, Cell Therapy, mRNA

    Therapeutic Areas

    Respiratory
    Allergy
    Quick Facts
    HQ:China
    Founded:2017
    Employees:548
    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 5 (≤1 µg/m³)
    Cytotoxic / ADC Handling

    Production Scales

    Commercial Scale
    Large Scale (Metric Ton+)

    Markets Served

    Asia-Pacific
    Regulatory Approvals
    Drug Approval 49FHMH
    FDA · #APR-D9PKDOO9 · 2020-10-01
    Drug Approval VSQRLL
    Health Canada · #APR-GO7HFQWI · 2021-08-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-ZJM7SBBF
    Issued: 2020-10-22
    Expires: 2025-07-28

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-T0Y629YY
    Issued: 2020-11-11
    Expires: 2025-02-19

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-3Y8497FO
    Issued: 2020-09-07
    Expires: 2025-10-11

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-FRKE4F6M
    Issued: 2020-09-05
    Expires: 2025-05-06
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    Key facts about Newland Pharmaceutical Co. Ltd

    • Newland Pharmaceutical Co. Ltd is headquartered in China.
    • Newland Pharmaceutical Co. Ltd was founded in 2017.
    • Newland Pharmaceutical Co. Ltd has 548 employees.
    • Newland Pharmaceutical Co. Ltd's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

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    CDMOs in ChinaCDMOs in AsiaBiologics Drug Substance CDMOsFormulation Development CDMOsSterile Injectable CDMOsOEB 5 (≤1 µg/m³) CDMOsCytotoxic / ADC Handling CDMOs
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