Kolon Biotech
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Excipients & Specialty Ingredients
Company Overview
About
Kolon Biotech is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:South Korea
Founded:1991
Employees:1,377
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
Kolon Biotech, Inc.
54-1, Gieopdosi 1-ro, Daesowon-myeon, Chungju-si, Chungcheongbuk-do, 27465
Site Capabilities
5 capabilitiesANALYSIS
API MANUFACTURE
LABEL
MANUFACTURE
PACK
Regulatory Approvals
Drug Approval 72SNXG
PMDA · #APR-P17CXT9W · 2019-12-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-JXRBFPY7
Issued: 2020-10-03
Expires: 2025-10-02
Health Canada GMP
Health Canada
Cert #: CERT-6BGHKF6O
Issued: 2020-10-20
Expires: 2025-02-12
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Key facts about Kolon Biotech
- Kolon Biotech is headquartered in South Korea.
- Kolon Biotech was founded in 1991.
- Kolon Biotech has 1,377 employees.
- Kolon Biotech has one manufacturing site listed on CDMO Hub, in Chungju-si, South Korea.
- Kolon Biotech's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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