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    Alphial

    CDMO
    Italy
    https://alphial.eu/

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    Manufacturing & Lab Equipment
    Company Overview

    About

    Alphial is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Gene Therapy, Cell Therapy, mRNA

    Therapeutic Areas

    Cardiovascular
    Endocrinology
    Quick Facts
    HQ:Italy
    Founded:2005
    Employees:2,748
    Capabilities & Services

    Core Capabilities

    • Sterile Injectable
    • Sterile Fill/Finish
    • Fill/Finish (Vials)

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Cartridge / Pen

    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 V1L1DT
    EMA · #APR-2OUSVW0A · 2021-12-01
    Drug Approval JQ4WZB
    Health Canada · #APR-7JYE04WZ · 2022-09-01
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-2MIQXH95
    Issued: 2020-03-10
    Expires: 2025-10-06

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-RJU672J9
    Issued: 2020-12-27
    Expires: 2025-10-19

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-ZFFU3HR6
    Issued: 2020-09-10
    Expires: 2025-08-21

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-XUQIZJW1
    Issued: 2020-04-03
    Expires: 2025-04-12
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    Key facts about Alphial

    • Alphial is headquartered in Italy.
    • Alphial was founded in 2005.
    • Alphial has 2,748 employees.
    • Alphial's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).

    Find CDMOs like Alphial

    Directory pages this company appears in, each with the full list of matching manufacturers.

    CDMOs in ItalyCDMOs in EuropeSterile Injectable CDMOsFill-Finish CDMOsFill/Finish (Vials) CDMOsCartridge / Pen CDMOsOEB 4 (1-10 µg/m³) CDMOs
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