Eudra GMP - Public Layout

MIA | GMP | API REG | WDA | GDP | Sites

Help

Tue 10 Nov 2026 12:41:19 BST

GMP Compliance Menu

GMP Certificates

Non-Compliance Report

The Certificate has been invalidated, invalidated date is : 2024-01-17

Print Preview

Print Preview (Short version)

Back To Search

Health Products Regulatory Authority

CERTIFICATE NUMBER: 33757/V12319/0001

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of IRELAND confirms the following:

The manufacturer: Eirgen Pharma Limited

Site address:

Westside Business Park, Old Kilmeaden Road, Waterford, X91 YV67, Ireland

OMS Organisation Id. / OMS Location Id.: ORG-100001095 / LOC-100000758

Has been inspected under the national inspection programme in accordance with Art. 88 of Regulation (EU) 2019/6.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-10-13 , it is considered that it complies with:

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

Part 2

Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.1  Capsules, hard shell
           1.2.1.2  Capsules, soft shell
           1.2.1.13  Tablets
   1.2.2  Batch certification

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           1.5.1.2  Capsules, soft shell
           1.5.1.13  Tablets
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.3 Chemical/Physical

Clarifying remarks (for public users):

Products manufactured may contain corticosteroids, substances with hormonal activity and cytotoxic substances The HPRA does not routinely issue hard copies of GMP certificates. Authenticity of GMP certification may be verified on the EudraGMDP database.

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.