Drug Product
Advanced Modalities
Regulatory, Tech Transfer & Support Services
Company Overview
About
Mycenax Biotech is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Taiwan
Founded:1994
Employees:991
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Europe
Regulatory Approvals
Drug Approval 7S8JG5
EMA · #APR-LJJXEEF9 · 2022-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
WHO GMP
World Health Organization
Cert #: CERT-6HD3L84W
Issued: 2020-01-27
Expires: 2025-06-01
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-DII43G47
Issued: 2020-07-03
Expires: 2025-02-24
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-FJ84SG3Q
Issued: 2020-07-09
Expires: 2025-05-01
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-OX5XE5X6
Issued: 2020-02-28
Expires: 2025-01-12
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Key facts about Mycenax Biotech
- Mycenax Biotech is headquartered in Taiwan.
- Mycenax Biotech was founded in 1994.
- Mycenax Biotech has 991 employees.
- Mycenax Biotech's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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