Drug Product
Company Overview
About
Polycine GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Germany
Founded:1996
Employees:604
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 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Global
Regulatory Approvals
Drug Approval J9E7GR
FDA · #APR-3N1Z3O9O · 2020-10-01
Drug Approval FE847H
FDA · #APR-CWMLS6DH · 2022-09-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-DWJNLGG1
Issued: 2020-02-22
Expires: 2025-02-07
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-BRTJUXS9
Issued: 2020-09-16
Expires: 2025-08-06
Health Canada GMP
Health Canada
Cert #: CERT-SM3SGP98
Issued: 2020-01-07
Expires: 2025-11-10
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-P6BP84EG
Issued: 2020-07-19
Expires: 2025-02-19
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Key facts about Polycine GmbH
- Polycine GmbH is headquartered in Germany.
- Polycine GmbH was founded in 1996.
- Polycine GmbH has 604 employees.
- Polycine GmbH's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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