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The Certificate has been withdrawn, withdrawn date is : 2025-09-15

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Landesdirektion Sachsen LDS

CERTIFICATE NUMBER: DE_SN_01_GMP_2023_0041

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended
Art. 63 of Regulation (EU) 536/2014 as amended

The competent authority of Germany confirms the following:

The manufacturer: ABX advanced biochemical compounds Biomedizinische Forschungsreagenzien GmbH

Site address:

Heinrich-Glaeser-Strasse 10-14, Radeberg, Saxony, 01454, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100012791 / LOC-100018392

Has been inspected under the national inspection programme in accordance with Art. 61 of Regulation (EU) No 536/2014 and Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Sect. 13 para 1 German Medicinal Product Act (manufacture) and § 72 German Medicinal Product Act (import).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2021-09-30 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (3)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

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

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/EC and Art. 15 of Directive 2001/20/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products
Human Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.4  Small volume liquids
                  Special Requirements:
                   5  Radiopharmaceuticals
   1.1.3  Batch certification

1.5 Packaging

1.5.2 Secondary packaging

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

Clarifying remarks (for public users):

This authorisation is only valid for the premises as detailed on the floor plans contained in the version of FB QS 092 (Appendices to the Site Master File [SMF QS 02]) noted by the Authority: - FB QS 092 (Seite 5): HGS10, Erdgeschoss, Herstellungs- und Kontrollbereich; - FB QS 092 (Seite 6): HGS10a, Erdgeschoss, Herstellungs- und Kontrollbereich; - FB QS 092 (Seite 10/11): HS10a, 1. Obergeschoss, Herstellungs- und Kontrollbereich. to 1.6.3: This authorisation only applies to the quality control tests contained in the version of the Site Master File (SMF QS 02, 7 Quality Control) noted by the Authority. to 1.6.4: This certificate is only valid for testing for bacterial endotoxins (Ph. Eur. 2.6.14).

Withdrawal comments in English: GMP certificate has been withdrawn. Reason: has been replaced by a new certificate: No. DE_SN_01_GMP_2025_0043 dated 11 September 2025

Withdrawal comments in National Language: Das GMP-Zertifikat wurde aufghoben. Begründung: ist ersetzt worden durch ein neues GMP-Zertifikat: Nr. DE_SN_01_GMP_2025_0043 vom 11. September 2025

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.