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The Certificate has been withdrawn, withdrawn date is : 2026-08-04

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Landesamt Fuer Gesundheit Und Soziales

CERTIFICATE NUMBER: DE_BE_01_GMP_2024_0007

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

Part 1

Issued following an inspection in accordance with
Art. 94(1) of Regulation (EU) 2019/6 as amended

The competent authority of Germany confirms the following:

The manufacturer: PenCef Pharma GmbH

Site address:

Breitenbachstrasse 13-14, Wittenau, Berlin, 13509, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100025169 / LOC-100034366

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_BE_01_MIA_2024_0008 in accordance with Art. 88 of Regulation (EU) 2019/6.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-09-01 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (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. 80(5) of Directive 2001/82/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

Veterinary 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:
                   1  B-lactam Antibiotics
           1.2.1.13  Tablets
                  Special Requirements:
                   1  B-lactam Antibiotics
   1.2.2  Batch certification

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
                  Special Requirements:
                   1  B-lactam Antibiotics
           1.5.1.8  Other solid dosage forms
                  Special Requirements:
                   1  B-lactam Antibiotics
           1.5.1.13  Tablets
                  Special Requirements:
                   1  B-lactam Antibiotics
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.3 Chemical/Physical

Clarifying remarks (for public users):

The marketing authorization is only valid for the production of medicinal products with APIs of the penicillin-group. 1.2.1.13: Tablets includes also film-coated tablets 1.5: In case of primary and secondary packaging it is allowed to combine medicinal products with APIs of the penicillin-group and medicinal products with other APIs (combi packs). The manufacturing authorisation is based on floor plans no. 1 to 11 from 23rd January 2024.

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_BE_01_GMP_2026_0039

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_BE_01_GMP_2026_0039

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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.