Excipients & Specialty Ingredients
Company Overview
About
Caregen Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:South Korea
Founded:2011
Employees:1,559
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Global
Manufacturing Facilities
1 site worldwide
Caregen Co., Ltd.
270 Gongdan-Ro, Gunpo
Regulatory Approvals
Drug Approval 9UJRNK
Health Canada · #APR-UB9V14XK · 2021-12-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-R2XB4PKP
Issued: 2020-05-02
Expires: 2025-03-04
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-XI6J6DFW
Issued: 2020-12-20
Expires: 2025-09-27
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-OCY4E70K
Issued: 2020-07-17
Expires: 2025-08-19
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Key facts about Caregen Co., Ltd.
- Caregen Co., Ltd. is headquartered in South Korea.
- Caregen Co., Ltd. was founded in 2011.
- Caregen Co., Ltd. has 1,559 employees.
- Caregen Co., Ltd. has one manufacturing site listed on CDMO Hub, in Gunpo, South Korea.
- Caregen Co., Ltd.'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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