Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Ardena is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Belgium
Founded:2014
Employees:1,195
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Global
Manufacturing Facilities
1 site worldwide
Ardena U.S. LLC
14 Schoolhouse Road, Somerset, New Jersey, 08873-1213
Site Capabilities
2 capabilitiesANALYSIS
MANUFACTURE
Regulatory Approvals
Drug Approval 0NO2CP
Health Canada · #APR-NV81G0BU · 2019-12-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-O0ZA21L8
Issued: 2020-02-03
Expires: 2025-12-04
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-TSIRETVP
Issued: 2020-12-27
Expires: 2025-09-08
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-QX5TS4WQ
Issued: 2020-09-21
Expires: 2025-05-09
WHO GMP
World Health Organization
Cert #: CERT-Y33RU31H
Issued: 2020-11-22
Expires: 2025-05-04
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Key facts about Ardena
- Ardena is headquartered in Belgium.
- Ardena was founded in 2014.
- Ardena has 1,195 employees.
- Ardena has one manufacturing site listed on CDMO Hub, in Somerset, United States.
- Ardena's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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