Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
PolyPeptide Group is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Belgium
Founded:2017
Employees:1,248
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
BSL-2 (Biosafety Level 2)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
Polypeptide Laboratories San Diego, LLC
9395 Cabot Drive, San Diego, California, 92126
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
Regulatory Approvals
Drug Approval LG94YM
Health Canada · #APR-KBIC1LJN · 2019-01-01
Drug Approval KL3QCU
PMDA · #APR-S92T1QBM · 2019-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-U5PDL7P6
Issued: 2020-03-18
Expires: 2025-09-24
Health Canada GMP
Health Canada
Cert #: CERT-DP64Z6MS
Issued: 2020-09-23
Expires: 2025-04-22
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Key facts about PolyPeptide Group
- PolyPeptide Group is headquartered in Belgium.
- PolyPeptide Group was founded in 2017.
- PolyPeptide Group has 1,248 employees.
- PolyPeptide Group has one manufacturing site listed on CDMO Hub, in San Diego, United States.
- PolyPeptide Group's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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