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    Nilogen Oncosystems

    CDMO
    United States
    https://www.nilogen.com/

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    Analytical & Bioanalytical Services
    Contract Research Organization
    Company Overview

    About

    Nilogen Oncosystems is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines

    Therapeutic Areas

    Infectious Disease
    Quick Facts
    HQ:United States
    Founded:2013
    Employees:313
    Capabilities & Services

    Core Capabilities

    • Small Molecule API
    • Small Molecule Drug Product
    • Oral Solid Dose

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Oral Solid Dose

    Containment Capabilities

    OEB 4 (1-10 µg/m³)

    Production Scales

    Pilot Scale
    Phase I Clinical Trials
    Clinical

    Markets Served

    Global
    Regulatory Approvals
    Drug Approval Z65ZZR
    Health Canada · #APR-S1A82HC7 · 2020-07-01

    Case Studies

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

    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-X7Y0LCXV
    Issued: 2020-06-16
    Expires: 2025-08-05

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-KE9UK7V4
    Issued: 2020-01-10
    Expires: 2025-11-18

    Health Canada GMP

    Health Canada
    Cert #: CERT-0JJ5PE1W
    Issued: 2020-09-24
    Expires: 2025-11-13
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    Key facts about Nilogen Oncosystems

    • Nilogen Oncosystems is headquartered in the United States.
    • Nilogen Oncosystems was founded in 2013.
    • Nilogen Oncosystems has 313 employees.
    • Nilogen Oncosystems's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.

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    CDMOs in United StatesCDMOs in North AmericaSmall Molecule API CDMOsSmall Molecule Drug Product CDMOsOral Solid Dose CDMOsOral Solid Dose CDMOsOEB 4 (1-10 µg/m³) CDMOs
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