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Austrian Federal Office For Safety In Health Care

CERTIFICATE NUMBER: 483036-103837225

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
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Austria confirms the following:

The manufacturer: Takeda Manufacturing Austria AG

Site address:

Industriestrasse 131, Donaustadt, Vienna, 1221, Austria

OMS Organisation Id. / OMS Location Id.: ORG-100000816 / LOC-100006117

Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/6 and Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-05-21 , it is considered that it complies with:

The principles of GMP for active substances referred to in Art. 123(6) of Regulation (EU) 2019/6 and 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:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

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/EC and 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
Veterinary Medicinal Products

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

[900000005237]Ammonium Sulfate Precipitate Antithrombin III (Intermediate for AT III NF Bulk)(en)

[900000005238]Factor IX Eluate (Intermediate for Ceprotin Bulk, Factor IX NF Bulk, Immunine Bulk)(en)

[900000005239]A1PI Zn/EDTA Concentrate (Intermediate for A1PI Bulk)(en)

[900000005240]Cryoprecipitate (Intermediate for Sealer Protein VH S/D Bulk, Immunate S/D Bulk)(en)

[900000005241]Feiba NF Eluate (Intermediate for Thrombin VH S/D Bulk, Feiba NF Bulk)(en)

[900000005242]Fraction V (Intermediate for Human Albumin)(en)

[900000005243]Human Albumin Bulk (Intermediate for Human Albumin)(en)

[900000005244]Factor VII Eluate (Intermediate for Factor VII NF Bulk Powder)(en)

[900000005245]Precipitate G (Intermediate for Immunglobulins)(en)

[900000005246]C1-Inhibitor Dialysat (Intermediate for C1-Inhibitor frozen for internal use)(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Ammonium Sulfate Precipitate Antithrombin III (Intermediate for AT III NF Bulk)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance Human

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation for further manufacturing in Benatzkygasse 2-6, 1221 Wien

Active Substance:Factor IX Eluate (Intermediate for Ceprotin Bulk, Factor IX NF Bulk, Immunine Bulk)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of intermediate for further manufacturing in Benatzkygasse 2-6, 1221 Wien

Active Substance:A1PI Zn/EDTA Concentrate (Intermediate for A1PI Bulk)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of intermediate for further manufacturing in Benatzkygasse 2-6, 1221 Wien

Active Substance:Cryoprecipitate (Intermediate for Sealer Protein VH S/D Bulk, Immunate S/D Bulk)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of intermediate for further manufacturing in Benatzkygasse 2-6, 1221 Wien

Active Substance:Feiba NF Eluate (Intermediate for Thrombin VH S/D Bulk, Feiba NF Bulk)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of intermediate for further manufacturing in Benatzkygasse 2-6, 1221 Wien

Active Substance:Fraction V (Intermediate for Human Albumin)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of intermediate for further manufacturing in Los Angeles, USA

Active Substance:Human Albumin Bulk (Intermediate for Human Albumin)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of intermediate for further manufacturing in Industriestraße 72, 1221 Wien

Active Substance:Factor VII Eluate (Intermediate for Factor VII NF Bulk Powder)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of intermediate for further manufacturing in Benatzkygasse 2-6, 1221 Wien

Active Substance:Precipitate G (Intermediate for Immunglobulins)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of intermediate for further manufacturing in Lessines, Belgium

Active Substance:C1-Inhibitor Dialysat (Intermediate for C1-Inhibitor frozen for internal use)

3.2 Extraction of Active Substance from Natural Sources

3.2.3  Extraction of substance from human source

3.2.6  Purification of extracted substance

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Preparation of intermediate for further manufacturing in Benatzkygasse 2-6, 1221 Wien

Clarifying remarks (for public users):

Takeda Manufacturing Austria AG; Distribution: *) Precipitate G: Distributed to Baxalta Belgium Manufacturing SA, Boulevard Ren Branquart 80, 7860 Lessines, Belgium *) Fraction V: Distributed to Baxter Healthcare Corporation, 4501 Colorado Boulevard, Los Angeles, CA 90039, USA Probebetrieb betreffend Verfahren INS-483036-100679918 bis / Regarding INS-483036-100679918 valid until: 12/2024 Mit 23.12.2021 wurde die Baxter AG in Takeda Manufacturing Austria AG umbenannt. / As of 23 December 2021 Baxter AG was renamed into Takeda Manufacturing Austria AG.

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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.