ENCell Co., Ltd.
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Advanced Modalities
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
ENCell Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:South Korea
Founded:1997
Employees:1,349
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 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval TCOIR6
Health Canada · #APR-PMUM3HAB · 2020-07-01
Drug Approval JY7KW0
FDA · #APR-2RC3AZ9Y · 2022-03-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-NI959D44
Issued: 2020-12-07
Expires: 2025-08-09
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-2PURUU7R
Issued: 2020-04-10
Expires: 2025-08-04
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Key facts about ENCell Co., Ltd.
- ENCell Co., Ltd. is headquartered in South Korea.
- ENCell Co., Ltd. was founded in 1997.
- ENCell Co., Ltd. has 1,349 employees.
- ENCell Co., Ltd.'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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