Eudra GMP - Public Layout

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

Help

Tue 10 Nov 2026 18:20:11 BST

GMP Compliance Menu

GMP Certificates

Non-Compliance Report

Print Preview

Print Preview (Short version)

Back To Search

Staatliches Gewerbeaufsichtsamt Hannover

CERTIFICATE NUMBER: DE_NI_02_GMP_2025_0058

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

Part 1

Issued following an inspection in accordance with
Art. 63 of Regulation (EU) 536/2014 as amended

The competent authority of Germany confirms the following:

The manufacturer: Richter BioLogics GmbH

Site address:

Feodor-Lynen-Strasse 5, Gross Buchholz, Hanover, 30625, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100011759 / LOC-100022410

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_NI_02_MIA_2025_0025 in accordance with Art. 61 of Regulation (EU) No 536/2014.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2025-11-26 , 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. 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 Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.1 Aseptically prepared (processing operations for the following dosage forms)
1.1.1.6 Other: Aseptically manufactured inactivated bacterial cells as active substances for vaccines only.(en)

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.6  Liquids for internal use
   1.2.2  Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.2  Immunological products
           1.3.1.4  Gene therapy products
           1.3.1.5  Biotechnology products
   1.3.2  Batch Certification (list of product types)
           1.3.2.2  Immunological products
           1.3.2.4  Gene therapy products
           1.3.2.5  Biotechnology products

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: Biotechnological manufacturing of active substances in bacterial cells by fermentation, cell disruption/lysis and purification via e.g. chromatography/filtration steps: Plasmid DNA, recombinant proteins and polysaccharides. Manufacturing of active substances (recombinant proteins) by cell-free protein synthesis (CFPS). Conjugation of proteins with polysaccharides to form active substances. Biotechnological manufacturing of living or inactivated bacterial cells as active substances by fermentation, inactivation and purification if necessary.(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.6  Liquids for internal use
   1.5.2  Secondary packaging

1.6 Quality control testing

   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

Clarifying remarks (for public users):

To no. 1.2.1.6, 1.3.2.2, 1.3.2.4, 1.3.2.5, 1.5.1.6 and 1.5.2: Products selected in no. 1.3.1.2, 1.3.1.4 and 1.3.1.5 only; to no. 1.2.1.6: buffer solution as a placebo, too. No batch release of products manufactured by cell-free protein synthesis (CFPS). To no. 1.2.2: Buffer solution as a placebo or oral powders only. To no. 1.3.1.2: Biotechnological manufacturing of active substances in bacterial cells by fermentation, cell disruption/lysis and purification via e.g. chromatography/filtration steps. Biotechnological manufacturing of living or inactivated bacterial cells as active substances by fermentation, inactivation and purification if necessary. Recombinant Proteins/DNA: Manufacturing of active substances for vaccines by cell-free protein synthesis (CFPS). To no. 1.3.1.4: Medicinal products containing genetically modified xenogeneic genes and medicinal products derived from genetically modified xenogeneic cells: Biotechnological manufacturing of active subs (text missing)

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.