Advanced Modalities
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
GC Cell is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:South Korea
Founded:2015
Employees:924
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
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval PVRX93
EMA · #APR-HKAT6RDP · 2019-07-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-OZIMCAR7
Issued: 2020-12-25
Expires: 2025-04-12
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-18UNPF44
Issued: 2020-05-16
Expires: 2025-10-27
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Key facts about GC Cell
- GC Cell is headquartered in South Korea.
- GC Cell was founded in 2015.
- GC Cell has 924 employees.
- GC Cell's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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