Excipients & Specialty Ingredients
Company Overview
About
FREY + LAU is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Germany
Founded:1994
Employees:2,224
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
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval G3KSHX
FDA · #APR-H4I4ZSE9 · 2019-05-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-QLY513AL
Issued: 2020-06-27
Expires: 2025-11-22
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-8XD4JUEK
Issued: 2020-12-13
Expires: 2025-01-24
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-P6ME7JUY
Issued: 2020-10-04
Expires: 2025-08-19
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Key facts about FREY + LAU
- FREY + LAU is headquartered in Germany.
- FREY + LAU was founded in 1994.
- FREY + LAU has 2,224 employees.
- FREY + LAU's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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