CKD BiO
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Drug Product
Company Overview
About
CKD BiO is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:South Korea
Founded:1998
Employees:325
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
CKD Bio Corporation
292, Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 156-04
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
5
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval O1RZN6
EMA · #APR-WKGJGECB · 2022-08-01
Drug Approval ZHLU9B
Health Canada · #APR-65RVSGO9 · 2021-04-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-JIJEUKPF
Issued: 2020-09-19
Expires: 2025-03-27
WHO GMP
World Health Organization
Cert #: CERT-OILULZ8E
Issued: 2020-06-25
Expires: 2025-12-14
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Key facts about CKD BiO
- CKD BiO is headquartered in South Korea.
- CKD BiO was founded in 1998.
- CKD BiO has 325 employees.
- CKD BiO has one manufacturing site listed on CDMO Hub, in Ansan-si, South Korea.
- CKD BiO's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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