Drug Product
Excipients & Specialty Ingredients
Company Overview
About
Galen-N Ltd. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Bulgaria
Founded:1991
Employees:1,251
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
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Global
Regulatory Approvals
Drug Approval NZ5QCW
EMA · #APR-7A4D4F9W · 2019-10-01
Drug Approval 2GGN39
EMA · #APR-VWD7WO4Z · 2020-01-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-2YA8CM6V
Issued: 2020-02-02
Expires: 2025-04-01
WHO GMP
World Health Organization
Cert #: CERT-2MAEEFR6
Issued: 2020-04-10
Expires: 2025-07-18
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Key facts about Galen-N Ltd.
- Galen-N Ltd. is headquartered in Bulgaria.
- Galen-N Ltd. was founded in 1991.
- Galen-N Ltd. has 1,251 employees.
- Galen-N Ltd.'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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