Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
SK bioscience is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:South Korea
Founded:2007
Employees:2,571
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
North America
International Regulatory
EU GMP Certificates
4
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval V7UM60
FDA · #APR-B69IWLAF · 2018-07-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-0E0BQAJP
Issued: 2020-02-27
Expires: 2025-11-23
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-S6O3L6HB
Issued: 2020-10-02
Expires: 2025-03-19
WHO GMP
World Health Organization
Cert #: CERT-FLB6DIK0
Issued: 2020-01-17
Expires: 2025-06-14
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-C3YUNVNI
Issued: 2020-05-25
Expires: 2025-09-26
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Key facts about SK bioscience
- SK bioscience is headquartered in South Korea.
- SK bioscience was founded in 2007.
- SK bioscience has 2,571 employees.
- SK bioscience's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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