Drug Product
Company Overview
About
CSL (incl. CSL Behring) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Australia
Founded:2016
Employees:2,141
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
CSL Behring (Australia) Pty Ltd
189-209 Camp Road, Broadmeadows, Victoria, 3047
Site Capabilities
1 capabilityMANUFACTURE
International Regulatory
EU GMP Certificates
6
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval SGWS9P
FDA · #APR-KIW4J3UV · 2021-08-01
Drug Approval EUU2XD
PMDA · #APR-NMAX61MD · 2018-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-R4KDDJ8V
Issued: 2020-09-04
Expires: 2025-01-04
WHO GMP
World Health Organization
Cert #: CERT-PG2WYD6B
Issued: 2020-09-10
Expires: 2025-10-02
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-LKOOGV0I
Issued: 2020-01-11
Expires: 2025-08-02
Health Canada GMP
Health Canada
Cert #: CERT-LFX1BV7G
Issued: 2020-11-17
Expires: 2025-08-13
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Key facts about CSL (incl. CSL Behring)
- CSL (incl. CSL Behring) is headquartered in Australia.
- CSL (incl. CSL Behring) was founded in 2016.
- CSL (incl. CSL Behring) has 2,141 employees.
- CSL (incl. CSL Behring) has one manufacturing site listed on CDMO Hub, in Broadmeadows, Australia.
- CSL (incl. CSL Behring)'s capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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