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Ministry Of Social Affairs Health Women And Family

CERTIFICATE NUMBER: DE_SL_01_GMP_2026_0020

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

The competent authority of Germany confirms the following:

The manufacturer: Fresenius Medical Care Deutschland GmbH

Site address:

Frankfurter Strasse 6-8, St. Wendel, 66606, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100001164 / LOC-100008782

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_SL_01_MIA_2026_0014 in accordance with 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 2026-05-21 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (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/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

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.1  Large volume liquids
   1.1.3  Batch certification

1.4 Other products or manufacturing activity

1.4.2 Sterilisation of active substance/ excipients/ finished product
1.4.2.3 Moist heat

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.6  Liquids for internal use
                  Special Requirements:
                   7  Other: Dialysis solutions(en)
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.1 Microbiological: sterility
1.6.3 Chemical/Physical

Clarifying remarks (for public users):

To 1.6.1: Testing of large volume parenterals for sterility and absence of endotoxins To 1.6.3: Testing of large volume parenterals for identity, purity and content Storage facility for documents (archiving of GMP-related documents): Rhenus Archiv Services GmbH Schmickstraße 14 60314 Frankfurt am Main Germany

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.