Drug Product
Analytical & Bioanalytical Services
Company Overview
About
Eirgen Pharma is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Ireland
Founded:2014
Employees:1,135
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Global
Manufacturing Facilities
1 site worldwide
Eirgen Pharma Ltd
Westside Business Park, Old Kilmeaden Road, Waterford, X, 91 YV67
Site Capabilities
6 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
RELABEL
REPACK
International Regulatory
EU GMP Certificates
6
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval KCC4EQ
Health Canada · #APR-FMUTRP38 · 2019-02-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-ZU59N16N
Issued: 2020-07-13
Expires: 2025-11-18
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-QKBZGFW3
Issued: 2020-09-15
Expires: 2025-12-13
WHO GMP
World Health Organization
Cert #: CERT-AQAUZLXR
Issued: 2020-11-16
Expires: 2025-06-21
Health Canada GMP
Health Canada
Cert #: CERT-XGHIAWMH
Issued: 2020-10-17
Expires: 2025-03-07
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Key facts about Eirgen Pharma
- Eirgen Pharma is headquartered in Ireland.
- Eirgen Pharma was founded in 2014.
- Eirgen Pharma has 1,135 employees.
- Eirgen Pharma has one manufacturing site listed on CDMO Hub, in Waterford, Ireland.
- Eirgen Pharma's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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