Drug Product
Company Overview
About
GL CHEMTEC is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Canada
Founded:2003
Employees:2,017
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
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval HMKLI8
EMA · #APR-170RAG3F · 2018-06-01
Drug Approval Q3P07G
EMA · #APR-X2C25BUE · 2019-01-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-XIWZRE4I
Issued: 2020-11-23
Expires: 2025-10-21
WHO GMP
World Health Organization
Cert #: CERT-OGU6558B
Issued: 2020-12-25
Expires: 2025-08-24
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-0C4VTEEX
Issued: 2020-12-17
Expires: 2025-01-23
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Key facts about GL CHEMTEC
- GL CHEMTEC is headquartered in Canada.
- GL CHEMTEC was founded in 2003.
- GL CHEMTEC has 2,017 employees.
- GL CHEMTEC's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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