Drug Product
Company Overview
About
Galenicum Health is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:Spain
Founded:2011
Employees:2,789
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Europe
International Regulatory
EU GMP Certificates
6
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval HO9KZG
Health Canada · #APR-9N0BTZ54 · 2020-03-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-3N9YKBOH
Issued: 2020-03-13
Expires: 2025-06-17
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-GNFXV8EW
Issued: 2020-12-09
Expires: 2025-08-22
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-KYCH3IEC
Issued: 2020-10-24
Expires: 2025-07-13
Health Canada GMP
Health Canada
Cert #: CERT-JGZR93N8
Issued: 2020-02-22
Expires: 2025-05-28
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Key facts about Galenicum Health
- Galenicum Health is headquartered in Spain.
- Galenicum Health was founded in 2011.
- Galenicum Health has 2,789 employees.
- Galenicum Health's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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