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    Formulytica

    CDMO
    Australia
    https://formulytica.com/

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

    About

    Formulytica is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals

    Therapeutic Areas

    Neurology
    Quick Facts
    HQ:Australia
    Founded:2000
    Employees:1,446
    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

    OEB 4 (1-10 µg/m³)

    Production Scales

    Commercial Scale
    Large Scale (Metric Ton+)

    Markets Served

    Global
    Regulatory Approvals
    Drug Approval KF7LFW
    EMA · #APR-SFXNJNJA · 2018-02-01
    Drug Approval TRQ8S8
    EMA · #APR-YFCFGQGV · 2018-08-01

    Case Studies

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

    Certifications

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-AENCMM5L
    Issued: 2020-10-11
    Expires: 2025-02-19

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-XL6L7LTN
    Issued: 2020-07-14
    Expires: 2025-05-15

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-E41AKUP3
    Issued: 2020-01-19
    Expires: 2025-10-22

    Health Canada GMP

    Health Canada
    Cert #: CERT-02643U9Q
    Issued: 2020-05-06
    Expires: 2025-01-18
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    Key facts about Formulytica

    • Formulytica is headquartered in Australia.
    • Formulytica was founded in 2000.
    • Formulytica has 1,446 employees.
    • Formulytica's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.

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    Fill-Finish CDMOsTopical / Transdermal CDMOsOEB 4 (1-10 µg/m³) CDMOs
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