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    Enteris BioPharma

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

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    Drug Product
    Analytical & Bioanalytical Services
    Regulatory, Tech Transfer & Support Services
    Company Overview

    About

    Enteris BioPharma is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization

    Therapeutic Areas

    Rare Disease
    Metabolic
    Quick Facts
    HQ:United States
    Founded:1998
    Employees:1,913
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Drug Product
    • Biologics Manufacturing

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Prefilled Syringe
    Sterile Injectable

    Production Scales

    Phase II
    Clinical
    Pilot Scale

    Markets Served

    North America
    Europe
    Regulatory Approvals
    Drug Approval E7TFKF
    Health Canada · #APR-HXRPPH68 · 2019-04-01
    Drug Approval 6QDY4N
    EMA · #APR-PU5B69N2 · 2020-08-01
    Certifications

    WHO GMP

    World Health Organization
    Cert #: CERT-NYJC3YRI
    Issued: 2020-01-05
    Expires: 2025-10-25

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-HNQ6BOF4
    Issued: 2020-07-04
    Expires: 2025-06-02

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-E1G2RGOA
    Issued: 2020-12-12
    Expires: 2025-12-24

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-LMLWMT95
    Issued: 2020-09-10
    Expires: 2025-10-03
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    Key facts about Enteris BioPharma

    • Enteris BioPharma is headquartered in the United States.
    • Enteris BioPharma was founded in 1998.
    • Enteris BioPharma has 1,913 employees.
    • Enteris BioPharma's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.

    Find CDMOs like Enteris BioPharma

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    CDMOs in United StatesCDMOs in North AmericaBiologics Drug Substance CDMOsBiologics Drug Product CDMOsPrefilled Syringe CDMOsSterile Injectable CDMOs
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