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Regierungspraesidium Tuebingen

CERTIFICATE NUMBER: DE_BW_01_GMP_2025_0205

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: Pfizer Manufacturing Deutschland GmbH

Site address:

Mooswaldallee 1, Bruehl, Freiburg Im Breisgau, Baden-Wuerttemberg, 79108, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100004089 / LOC-100002851

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_BW_01_MIA_2025_0079 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 2025-07-02 , 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

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.1  Capsules, hard shell
                  Special Requirements:
                   7  Other: Medicinal products with high-potent active substances(en)
           1.2.1.8  Other solid dosage forms
                  Special Requirements:
                   7  Other: Medicinal products with high-potent active substances(en)
           1.2.1.13  Tablets
                  Special Requirements:
                   7  Other: Medicinal products with high-potent active substances(en)
           1.2.1.17  Other: Granules for further processing(en)
   1.2.2  Batch certification

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
                  Special Requirements:
                   7  Other: Medicinal products with high-potent active substances(en)
           1.5.1.2  Capsules, soft shell
           1.5.1.8  Other solid dosage forms
                  Special Requirements:
                   7  Other: Medicinal products with high-potent active substances(en)
           1.5.1.13  Tablets
                  Special Requirements:
                   7  Other: Medicinal products with high-potent active substances Immuno-suppressives (API: Sirolimus)(en)
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

2.1.2 Microbiological: non-sterility
2.1.3 Chemical/Physical

2.2 Batch certification of imported medicinal products

2.2.2 Non-sterile products

2.3 Other importation activities

2.3.1 Site of physical importation
2.3.2 Importation of intermediate which undergoes further processing

Clarifying remarks (for public users):

The authorisation is based on floor plans referenced on page 1 of document CD-1516 Appendix 6b (Version 36.0). 1.2.1.8: granules, pellets. 1.2.1.13 / 1.5.1.13: Tablets includes coated tablets. Special Requirements: Products with special requirements in terms of EU-GMP-Guide Part I, numbers 3.6 and 5.17 to 5.22: 1.2.1.1 / 1.2.1.8 / 1.2.1.13 / 1.5.1.1 / 1.5.1.8 / 1.5.1.13: Manufacturing of medicinal products with high-potent active substances in buildings K, M and R (bulk manufacturing) and building D/E (bulk manufacturing in rooms E-0-133, E-0-135, E-0-136 und E-0-137; primary packaging in rooms D-0-40, D-0-41, D-0-43, D-1-140 and D-1-130), for which dedicated facilities/equipment however are not mandatory. 1.5.1.13: Primary packaging of Immuno-supressives ist restricted to packaging of coated tablets with the API Sirolimus in dedicated room D-1-120. 1.6.3: The authorisation covers the real-time-release-testing of Apixaban film-coated tablets. Equipment for (text missing)

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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.