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    3. /Boston Institute of Biotechnology (BIB)
    Boston Institute of Biotechnology (BIB) logo

    Boston Institute of Biotechnology (BIB)

    CDMO
    United States
    https://bostonbib.com/

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

    About

    Boston Institute of Biotechnology (BIB) is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals

    Therapeutic Areas

    Respiratory
    Allergy
    Quick Facts
    HQ:United States
    Founded:2003
    Employees:1,572
    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

    Commercial Scale
    Large Scale (Metric Ton+)

    Markets Served

    Global
    Regulatory Approvals
    Drug Approval 12O5YF
    Health Canada · #APR-XI1IIFYR · 2021-10-01
    Drug Approval FIS6W2
    EMA · #APR-HBYW5WNF · 2020-02-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-Z7EZZD7K
    Issued: 2020-09-19
    Expires: 2025-02-13

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-1EUP1HC1
    Issued: 2020-12-05
    Expires: 2025-05-05

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-ASD6KB6F
    Issued: 2020-11-18
    Expires: 2025-06-05

    Health Canada GMP

    Health Canada
    Cert #: CERT-625VXV7L
    Issued: 2020-04-05
    Expires: 2025-11-19
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    Key facts about Boston Institute of Biotechnology (BIB)

    • Boston Institute of Biotechnology (BIB) is headquartered in the United States.
    • Boston Institute of Biotechnology (BIB) was founded in 2003.
    • Boston Institute of Biotechnology (BIB) has 1,572 employees.
    • Boston Institute of Biotechnology (BIB)'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

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    CDMOs in United StatesCDMOs in North AmericaBiologics Drug Substance CDMOsFormulation Development CDMOsSterile Injectable CDMOsOEB 4 (1-10 µg/m³) CDMOs
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