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The Certificate has been withdrawn, withdrawn date is : 2025-07-10

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Ministry Of Social Affairs Health Women And Family

CERTIFICATE NUMBER: DE_SL_01_GMP_2024_0004

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: K.D. Pharma Bexbach GmbH

Site address:

Am Kraftwerk 6-8, Bexbach, Saarland, 66450, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100016421 / LOC-100025203

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 2023-04-19 , it is considered that it complies with:

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

1.3 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

1.6 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

2.1.3 Chemical/Physical

2.2 Batch certification of imported medicinal products

2.2.2 Non-sterile products

2.3 Other importation activities

2.3.4 Other: The Product lcosapentosan EQ - Import of fish oil raw materials from Japan from the supplier Bizen Chemical Co., Ltd., Japan, for the exclusive manufacture of finished products for export to the USA.(en)

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

[00021041-00001]Eicosapentaensaeure 90 Ethylester (incl. Icosapent ethyl) Standard abbreviation: EPA90EE(en)

[00021041-00002]Eicosapentaensaeure Freie Fettsaeure Standard abbreviation: EPA-FFA(en)

[00021041-00003]Omega-3-Saeurenethylester 60 Standard abbreviation: Omega-3 EE(en)

[00021041-00004]Omega-3-Saeurenethylester 90 Standardabkuerzung: Omega-3 EE(en)

[00021041-00005]Docosahexaensaeure Standardabkuerzung: DHA(en)

[00021041-00006]Omega-3 Freie Fettsaeure (incl. Omega-3 carboxylic acids)(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Eicosapentaensaeure 90 Ethylester (incl. Icosapent ethyl) Standard abbreviation: EPA90EE

3.2 Extraction of Active Substance from Natural Sources

3.2.2  Extraction of substance from animal source

3.2.5  Modification of extracted substance Animal

3.2.6  Purification of extracted substance Animal

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Eicosapentaensaeure Freie Fettsaeure Standard abbreviation: EPA-FFA

3.2 Extraction of Active Substance from Natural Sources

3.2.2  Extraction of substance from animal source

3.2.5  Modification of extracted substance Animal

3.2.6  Purification of extracted substance Animal

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Omega-3-Saeurenethylester 60 Standard abbreviation: Omega-3 EE

3.2 Extraction of Active Substance from Natural Sources

3.2.2  Extraction of substance from animal source

3.2.5  Modification of extracted substance Animal

3.2.6  Purification of extracted substance Animal

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Omega-3-Saeurenethylester 90 Standardabkuerzung: Omega-3 EE

3.2 Extraction of Active Substance from Natural Sources

3.2.2  Extraction of substance from animal source

3.2.5  Modification of extracted substance Animal

3.2.6  Purification of extracted substance Animal

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Docosahexaensaeure Standardabkuerzung: DHA

3.2 Extraction of Active Substance from Natural Sources

3.2.2  Extraction of substance from animal source

3.2.5  Modification of extracted substance Animal

3.2.6  Purification of extracted substance Animal

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Omega-3 Freie Fettsaeure (incl. Omega-3 carboxylic acids)

3.2 Extraction of Active Substance from Natural Sources

3.2.2  Extraction of substance from animal source

3.2.5  Modification of extracted substance Animal

3.2.6  Purification of extracted substance Animal

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Clarifying remarks (for public users):

To 1.3.1.6 Human or animal extracted products: Fatty acids from marine oils. Regarding points 3.2 ff.: Supercritical Fluid Chromatography (SFC) End product treatment (including optional addition of antioxidants, final mixing and filtration) Bottling

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_SL_01_GMP_2025_0020

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_SL_01_GMP_2025_0020

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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.