Excipients & Specialty Ingredients
Company Overview
About
Colorcon is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Neurology
Quick Facts
HQ:China
Founded:2001
Employees:2,505
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
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
North America
International Regulatory
EU GMP Certificates
3
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval E5ME2N
PMDA · #APR-7UEFLAAW · 2018-03-01
Drug Approval 4T72YL
Health Canada · #APR-GTV5IM6D · 2022-04-01
Certifications
WHO GMP
World Health Organization
Cert #: CERT-MOSF1OTH
Issued: 2020-07-08
Expires: 2025-06-19
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-L2L7Q3BJ
Issued: 2020-04-24
Expires: 2025-05-16
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-NW7CGPIX
Issued: 2020-10-25
Expires: 2025-03-07
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-SWCN2XZ6
Issued: 2020-06-22
Expires: 2025-02-27
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Key facts about Colorcon
- Colorcon is headquartered in China.
- Colorcon was founded in 2001.
- Colorcon has 2,505 employees.
- Colorcon's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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