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Austrian Agency For Health And Food Safety

CERTIFICATE NUMBER: 481922-101174956

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
Art. 94(1) of Regulation (EU) 2019/6 as amended
Art. 63 of Regulation (EU) 536/2014 as amended

The competent authority of Austria confirms the following:

The manufacturer: Sandoz GmbH

Site address:

Biochemiestraße 10, Kundl, Tirol, 6250, Austria

OMS Organisation Id. / OMS Location Id.: ORG-100000546 / LOC-100000450

Other

(Human) API-A123(6)-R2019/6/EU,API-A111(1)-D2001/83/EC,NIP-A40-D2001/83/EC

(Veterinary) NIP-A88-R2019/6/EU

(Investigational product) NIP-A88-R2019/6/EU

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-06-23 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (3)

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. 111(5) of Directive 2001/83/EC, Art. 80(5) of Directive 2001/82/EC and Art. 15 of Directive 2001/20/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
Human Investigational Medicinal Products
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.3 Batch certification

1.3 Biological medicinal products (list of product types)

1.3.2 Batch Certification (list of product types)
1.3.2.5 Biotechnology products

1.4 Other products or manufacturing activity

1.4.3 Other: Herstellung nicht steriler wässriger Plasmid Lösungen aus bakterieller Fermentation (E. coli Zellen) / Manufacture of non-sterile aqueous plasmid solutions by bacterial fermentation (E. coli cells) Herstellung von RNA Impfstoff (CV2 mRNA) und intermediate Bulk / Manufacture of RNA vaccine (CV2 mRNA) and intermediate bulk Herstellung von Master Cell Banks (MCB) und / oder Working Cell Banks (WCB) / Manufacture of master cell banks and / or working cell banks, Herstellung nicht steriler wässriger Plasmid Lösungen aus bakterieller Fermentation (E. coli Zellen) / Manufacture of non-sterile aqueous plasmid solutions by bacterial fermentation (E. coli cells) Herstellung von RNA Impfstoff (CV2 mRNA) und intermediate Bulk / Manufacture of RNA vaccine (CV2 mRNA) and intermediate bulk Herstellung von Master Cell Banks (MCB) und / oder Working Cell Banks (WCB)/ Manufacture of master cell banks and / or working cell banks(en)

1.6 Quality control testing

1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

2.1.3 Chemical/Physical

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

[900000005393]Filgrastim (r-human Granulocyte Colony-Stimulating Factor; rhG-CSF, EP2006)(en)

[900000005395]Somatropin (r-human Growth Hormone in high concentrated form, rhGH, EP2000 HCF)(en)

[900000005394]Somatropin (r-human Growth Hormone; rhGH, EP2000)(en)

[900000005396]Calcitonin - salmon (linear polypeptide hormone; rsCT)(en)

[900000005397]Neisserial Heparin Binding Antigen (recombinant fusion protein; NHBA, MenB 287-953)(en)

[900000005398]Factor H binding protein (recombinant fusion protein; fHbp, MenB 936-741)(en)

[900000005399]Recombinant proteins Neisserial adhesin A (NadA, MenB 961c)(en)

[900000005400]Metreleptin (r-human leptin, LPT)(en)

[900000005401]r-Glucagon (single-chain polypeptide hormone, rGLG)(en)

[900000005402]Eptinezumab (humanized monoclonal antibody; ALD403)(en)

[900000005403]Brolucizumab (humanized single-chain antibody fragment; RTH258)(en)

[900000005404]Growth differentiation factor 15 (MBL949)(en)

[900000005619]Ensovibep (SKO136)(en)

[900000005620]FXT508 (antibody fragment)(en)

[900000005405]Certolizumab pegol (humanized monoclonal antibody fragment, pegylated; CDP870)(en)

[900000005406]Capsid protein Qβ (r-CAD106)(en)

[900000005621]Pegfilgrastim (pegylated r-human Granulocyte Colony-Stimulating Factor, pegylated rhG-CSF, LA-EP2006, Long – Acting EP2006, Ziextenzo)(en)

[900000005622]CV2 mRNA (mRNA - SARS-CoV2 and INFLUENZA antigen variants)(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Filgrastim (r-human Granulocyte Colony-Stimulating Factor; rhG-CSF, EP2006)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Somatropin (r-human Growth Hormone in high concentrated form, rhGH, EP2000 HCF)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Somatropin (r-human Growth Hormone; rhGH, EP2000)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Calcitonin - salmon (linear polypeptide hormone; rsCT)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Neisserial Heparin Binding Antigen (recombinant fusion protein; NHBA, MenB 287-953)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Factor H binding protein (recombinant fusion protein; fHbp, MenB 936-741)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Recombinant proteins Neisserial adhesin A (NadA, MenB 961c)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Metreleptin (r-human leptin, LPT)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:r-Glucagon (single-chain polypeptide hormone, rGLG)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Eptinezumab (humanized monoclonal antibody; ALD403)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Brolucizumab (humanized single-chain antibody fragment; RTH258)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Growth differentiation factor 15 (MBL949)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Ensovibep (SKO136)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:FXT508 (antibody fragment)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.5  Other:
ad. 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Certolizumab pegol (humanized monoclonal antibody fragment, pegylated; CDP870)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.4  Modification

3.3.5  Other:
ad 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Capsid protein Qβ (r-CAD106)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.4  Modification

3.3.5  Other:
ad 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Pegfilgrastim (pegylated r-human Granulocyte Colony-Stimulating Factor, pegylated rhG-CSF, LA-EP2006, Long – Acting EP2006, Ziextenzo)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.3  Isolation / Purification

3.3.4  Modification

3.3.5  Other:
ad 3.3.1 Bakterien / bacteria

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:CV2 mRNA (mRNA - SARS-CoV2 and INFLUENZA antigen variants)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.3  Isolation / Purification

3.3.4  Modification

3.3.5  Other:
Linearization of DNA Plasmid and in vitro transcription of mRNA from linearized DNA Plasmid

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:
Physical processing steps: Formulation of API with nano particles, purification and filtration

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Clarifying remarks (for public users):

Einschließlich Lagerung von Master- und/oder Working Cell Banks / including storage of master cell banks and/or working cell banks Probebetrieb betreffend folgender Verfahren gültig bis / Regarding the following inspection cases valid until 12/2025: INS-481922-100953724 INS-481922-14017241 INS-481922-100710049 INS-481922-100738393

Withdrawal comments in English: The licence issued in accordance with § 63 para 1 or § 63a para 2 or 3 or § 65 para 1 shall become void if the operating licence holder relinquishes it (austrian medicinal products act).

Withdrawal comments in National Language: The licence issued in accordance with § 63 para 1 or § 63a para 2 or 3 or § 65 para 1 shall become void if the operating licence holder relinquishes it (austrian medicinal products act).

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

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.