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The Certificate has been withdrawn, withdrawn date is : 2024-10-15

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Regierungspraesidium Tuebingen Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg

CERTIFICATE NUMBER: DE_BW_01_GMP_2023_0198

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: Corden Pharma GmbH

Site address:

Otto-Hahn-Strasse 1, Plankstadt, Baden-Wuerttemberg, 68723, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100011639 / LOC-100021495

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_BW_01_MIA_2022_0118 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 2023-09-06 , 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
           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: Intermediates: Tablet cores for further processing(en)
   1.2.2  Batch certification

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           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(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

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
           2.2.1.2  Terminally sterilised
   2.2.2  Non-sterile products

2.3 Other importation activities

2.3.1 Site of physical importation

Clarifying remarks (for public users):

The authorisation is based on the floor plans in document 06D35 PD009393 37 dated July 21, 2023. 1.2.1.8 / 1.5.1.8: granules and powders. 1.2.1.13 / 1.5.1.13: Tablets includes coated tablets. Special Requirements in terms of EU-GMP-Guide Part 1, numbers 3.6 and 5.17 to 5.22: Products, for which dedicated facilities/equipment however are not mandatory: Bulk manufacturing is restricted to buildings 36, 5 (GP-Sector, Sector O11) and 33 (HP-Sector); primary packaging is restricted to buildings 4 (coated tablets only), 5 (GP-Sector) and 33 (HP-Sector). Dedicated Areas for manufacturing of veterinary medcinal products with APIs Sarolaner, Moxidectin and Pyrantelpamoat in building 15 (bulk manufacturing) and building 12 (primary packaging) and for primary packaging of medicinal products with API L-Tyroxin in building 12. Authorised manufacturing does NOT cover blood products, immunological products (sera, vaccines, allergens, testsera and testantigenes) gene therapy (text missing)

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_BW_01_GMP_2024_0175

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_BW_01_GMP_2024_0175

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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.