Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Celltrion is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:South Korea
Founded:2014
Employees:1,311
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 II
Clinical
Pilot Scale
Markets Served
Global
Manufacturing Facilities
1 site worldwide
CELLTRION Inc
23, Academy-ro, Yeonsu-gu, Incheon, 22014
Site Capabilities
5 capabilitiesANALYSIS
API MANUFACTURE
LABEL
MANUFACTURE
PACK
International Regulatory
EU GMP Certificates
7
WHO Prequalified Products
6
Regulatory Bodies
EMA/EudraGMDP
WHO
Regulatory Approvals
Drug Approval 3NETGB
PMDA · #APR-N1UXVJOX · 2019-11-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-R9WJVT3D
Issued: 2020-01-08
Expires: 2025-12-04
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-LG0I6QBX
Issued: 2020-07-17
Expires: 2025-11-17
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Key facts about Celltrion
- Celltrion is headquartered in South Korea.
- Celltrion was founded in 2014.
- Celltrion has 1,311 employees.
- Celltrion has one manufacturing site listed on CDMO Hub, in Incheon, South Korea.
- Celltrion's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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