Mycenax Biotech
Taiwan
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
Technology Platforms
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
Manufacturing Facilities
1 site worldwide
Mycenax Biotech - Taiwan Facility
Taiwan
Site Capabilities
Solid Dose Manufacturing
Oral Liquids
Topicals
Regulatory Approvals
Drug Approval 7S8JG5
EMA · #APR-LJJXEEF9 · 2022-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
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
Customer Reviews
4.7
Overall Rating
Project Management4.7
Technology Transfer4.9
On-Time Delivery5.0
Communication Responsiveness4.1
Innovation4.8
Company Documents
No documents available.
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