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Bezirksregierung Duesseldorf

CERTIFICATE NUMBER: DE_NW_03_GMP_2026_0059

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. 15 of Directive 2001/20/EC as amended

The competent authority of Germany confirms the following:

The manufacturer: Bayer AG

Site address:

Friedrich-Ebert-Strasse 217-333, Elberfeld West, Wuppertal, 42117, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100000011 / LOC-100023212

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_NW_03_MIA_2026_0035 in accordance with Art. 13 of Directive 2001/20/EC, transposed in the following national legislation:Sect. 13 para 1 German Medicinal Product Act (manufacture) and § 72 German Medicinal Product Act (import).

Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:Sect. 64 para 1 and 3 German Medicinal Product Act.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2025-11-21 , 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)

The principles of GMP for active substances referred to in Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC transposed in the following national legislation:Sect. 64 para 1 and 3 German Medicinal Product Act.

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

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: 1.Biotechnol. APIacc.to§4(19)AMG: a) in bldg.151(CellCulturePilotPlant), bldg.46(CellCulturePilotPlant) &bldg.226(Biol. Pilot Plant, freezing process only) the manuf. of recombinant human monoclonal antibodies&antibody fragments, aswellas proteins +fusion proteins, takes place b) in bldg.151(CellCulturePilotPlant) +bldg.132, the chem. &biochem. modification of recombinant human monoclonal antibodies &antibody fragments, proteins +fusion proteins takes place. This includes, among others, the enzymatic digestion of proteins and antibodies and conjugation with pharmacologically active, low-molecular-weight substances. c) Gene therapeutics as ATMP The manufacturing activity exclusiv. incl. batch release of the finished product 2. Chemical API: a) including micronization(bldg.132) b) including acc.to §13(1)No.3 AMG, where during synthesis in the Bergkamen site also microorganisms were used finalized at the Elberfeld plant(en)

1.6 Quality control testing

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

2 IMPORTATION OF MEDICINAL PRODUCTS

2.2 Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
   2.2.3  Biological medicinal products
           2.2.3.3  Cell therapy products
           2.2.3.4  Gene therapy products

2.3 Other importation activities

   2.3.1  Site of physical importation
   2.3.3  Biological active substance
   2.3.4  Other: 2.3.4 Biological Active Substance Subject to permission in accordance with sect 13 (1) AMG: (1) Anti-a2AP (Bay 3018250) (2) IgG-ANP (Bay 2701250) (3) Anti-CCR8 (Bay 3375968) (4) anti-Sema 3A (Bay 3401016) Delivering companies: No. 1-4: Bayer Healthcare LLC, 800 Dwight Way, Berkeley, CA 94710 USA (until 26/03/2027).(en)

Clarifying remarks (for public users):

Manufacturing of active substances: The certificate is valid for following active substances: a) biological active substances Acarbose Monoclonal antibodies, antibody fragments, proteins and fusion proteins and their conjugates products b) chemical active substances Acoramidis Asundexian Ciprofloxacin Ciprofloxacin HCl Ciprofloxacin hydrated Darolutamide DTPA (Diethylentriamine pentaacetic acid) Finerenone Fludarabine phosphate Iloprost Moxifloxacin HCl Nifurtimox Regorafenib Riociguat Rivaroxaban Sevabertinib Vericiguat Quality Control testing: The certificate include also quality control of active ingredients, human investigational medicinal products and finished medicinal products: - Copanlisib Dihydrochlorid - Larotrectinib sulphate (only analytical QC-testing) - Molidustat Natrium - Nifedipine - Nimodipine - Nisoldipine - Nitrendipine - Sorafenib Tosylat (nur für analytische QC-Prüfung) Testing is carried out in quality control labs of Bayer AG in Wuppertal (text missing)

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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.