Analytical & Bioanalytical Services
Contract Research Organization
Clinical Trial Supply & Logistics
Regulatory, Tech Transfer & Support Services
Company Overview
About
Texcell Group is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:China
Founded:2004
Employees:192
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
Phase I Clinical Trials
Clinical
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
Texcell - North America, Inc.
4998 International Blvd, Frederick, Maryland, 21703
Site Capabilities
1 capabilityANALYSIS
Regulatory Approvals
Drug Approval MZSKP2
EMA · #APR-NM6F03Z5 · 2021-03-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-FBEAE6I6
Issued: 2020-12-20
Expires: 2025-08-17
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-2JCG2SVU
Issued: 2020-09-12
Expires: 2025-06-15
Health Canada GMP
Health Canada
Cert #: CERT-I7HHA7YC
Issued: 2020-01-27
Expires: 2025-10-10
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Key facts about Texcell Group
- Texcell Group is headquartered in China.
- Texcell Group was founded in 2004.
- Texcell Group has 192 employees.
- Texcell Group has one manufacturing site listed on CDMO Hub, in the United States.
- Texcell Group's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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