Samsung Biologics
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Advanced Modalities
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Samsung Biologics is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:South Korea
Founded:1990
Employees:2,340
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Global
Manufacturing Facilities
1 site worldwide
Samsung Biologics Co., Ltd.
300, Songdo bio-daero, Yeonsu-gu, Incheon, 21987
Site Capabilities
5 capabilitiesANALYSIS
API MANUFACTURE
LABEL
MANUFACTURE
PACK
International Regulatory
EU GMP Certificates
12
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 9KBZ21
EMA · #APR-IPGS66DH · 2022-04-01
Drug Approval 3HPY77
Health Canada · #APR-87UBLXLC · 2022-05-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-VLTFJF9X
Issued: 2020-12-16
Expires: 2025-01-23
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-9MWLK0YL
Issued: 2020-05-16
Expires: 2025-01-06
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Key facts about Samsung Biologics
- Samsung Biologics is headquartered in South Korea.
- Samsung Biologics was founded in 1990.
- Samsung Biologics has 2,340 employees.
- Samsung Biologics has one manufacturing site listed on CDMO Hub, in Incheon, South Korea.
- Samsung Biologics's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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