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The Certificate has been withdrawn, withdrawn date is : 2026-08-06

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Landesamt Fuer Arbeitsschutz Soziales Und Gesundheit Schleswig-Holstein

CERTIFICATE NUMBER: DE_SH_01_GMP_2026_0010

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

The competent authority of Germany confirms the following:

The manufacturer: Nordmark Pharma GmbH

Site address:

Pinnauallee 4, Uetersen, Schleswig-Holstein, 25436, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100031861 / LOC-100049855

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_SH_01_MIA_2026_0005 in accordance with 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).

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 2025-07-10 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (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/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

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.1 Aseptically prepared (processing operations for the following dosage forms)
1.1.1.6 Other: Active pharmaceutical ingredient (API): collagenase(en)

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
           1.2.1.13  Tablets
           1.2.1.17  Other: Granules Powder Pellets(en)
   1.2.2  Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.6  Human or animal extracted products
   1.3.2  Batch Certification (list of product types)
           1.3.2.6  Human or animal extracted products

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           1.5.1.13  Tablets
           1.5.1.17  Other non-sterile medicinal products: Granules Powder Pellets(en)
   1.5.2  Secondary packaging

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

Manufacture of active substance. Names of substances subject to inspection:

[00024994-00002]Tannin Protein Granulate of hen's egg white, non-sterile(en)

[00024994-00004]Pancreas powder Ph. Eur. from pig's pancreas (incl. pellets) non-sterile(en)

[00024994-00005]Pancrelipase USP from pig's pancreas, non-sterile(en)

[00024994-00008]Desiccated Thyroid Extract respectively degreased, dried, pulverized extract from pig's thyroids according to USP "Thyroid" non-sterile(en)

[00024994-00009]Collagenase N sterile filtered from the strain Clostridium histolyticum(en)

[00024994-00010]-r-L-Asparaginase from genetically modified Escherichia coli (E. coli), non-sterile(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Tannin Protein Granulate of hen's egg white, non-sterile

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:Pancreas powder Ph. Eur. from pig's pancreas (incl. pellets) non-sterile

3.2 Extraction of Active Substance from Natural Sources

3.2.2  Extraction of substance from animal source

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:Pancrelipase USP from pig's pancreas, non-sterile

3.2 Extraction of Active Substance from Natural Sources

3.2.2  Extraction of substance from animal source

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:Desiccated Thyroid Extract respectively degreased, dried, pulverized extract from pig's thyroids according to USP "Thyroid" non-sterile

3.2 Extraction of Active Substance from Natural Sources

3.2.2  Extraction of substance from animal source

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:Collagenase N sterile filtered from the strain Clostridium histolyticum

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.4 Manufacture of sterile Active Substance

3.4.1  Aseptically prepared

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.3  Microbiological testing including sterility testing

3.6.4  Biological Testing

Active Substance:-r-L-Asparaginase from genetically modified Escherichia coli (E. coli), non-sterile

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Clarifying remarks (for public users):

To 1.3.1.6 Solid dosage forms with active pharmaceutical ingredients of animal origin Parts of the Manufacturing site are located at Werftweg 4a, D-25436 Moorrege

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_SH_01_GMP_2026_0035

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_SH_01_GMP_2026_0035

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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.