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    AMPAC Analytical (an SK pharmteco company)

    CDMO
    United States
    https://www.skpharmteco.com/analytical-services/

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    Analytical & Bioanalytical Services
    Company Overview

    About

    AMPAC Analytical (an SK pharmteco company) is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Quality Control, Stability Testing, Method Development

    Therapeutic Areas

    Neurology
    Quick Facts
    HQ:United States
    Founded:2018
    Employees:1,700
    Capabilities & Services

    Core Capabilities

    • Cytotoxic / ADC Handling
    • High-Potency API
    • Sterile Fill/Finish

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Topical / Transdermal

    Containment Capabilities

    Cytotoxic / ADC Handling

    Production Scales

    Commercial Scale
    Large Scale (Metric Ton+)

    Markets Served

    North America
    Regulatory Approvals
    Drug Approval ZH0D1W
    FDA · #APR-ZREYV3V2 · 2022-02-01

    Case Studies

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

    Certifications

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-HSNDT73J
    Issued: 2020-03-07
    Expires: 2025-03-13

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-6IAY5LDS
    Issued: 2020-03-02
    Expires: 2025-08-21

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-F9M6LLND
    Issued: 2020-09-02
    Expires: 2025-11-13
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    Key facts about AMPAC Analytical (an SK pharmteco company)

    • AMPAC Analytical (an SK pharmteco company) is headquartered in the United States.
    • AMPAC Analytical (an SK pharmteco company) was founded in 2018.
    • AMPAC Analytical (an SK pharmteco company) has 1,700 employees.
    • AMPAC Analytical (an SK pharmteco company)'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.

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    CDMOs in United StatesCDMOs in North AmericaFill-Finish CDMOsTopical / Transdermal CDMOsCytotoxic / ADC Handling CDMOs
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