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The Certificate has been withdrawn, withdrawn date is : 2026-07-16

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Austrian Agency For Health And Food Safety

CERTIFICATE NUMBER: 484296-101532805

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: Novartis Pharmaceutical Manufacturing GmbH

Site address:

Biochemiestrasse 10, Kundl, Tirol, 6250, Austria

OMS Organisation Id. / OMS Location Id.: ORG-100045162 / LOC-100075588

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-A61-R2014/536/EU

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-02-15 , 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

1.2 Non-sterile products

1.2.2 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

   1.6.1  Microbiological: sterility
   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

   2.1.1  Microbiological: sterility
   2.1.2  Microbiological: non-sterility
   2.1.3  Chemical/Physical
   2.1.4  Biological

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

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

[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)

[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)

[900000005649]Recombinant Neisseria meningitidis serogroup B fHbp 2-3-1.13NB fusion protein (rP231)(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)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

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

3.5 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)

3.5.4  Other:
Formulation of API with nano particles, purification and filtration

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: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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:Recombinant Neisseria meningitidis serogroup B fHbp 2-3-1.13NB fusion protein (rP231)

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological 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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Clarifying remarks (for public users):

Hersteller Wirkstoffe: Novartis Pharmaceutical Manufacturing GmbH; Einschließlich Lagerung von Master- und/oder Working Cell Banks / including storage of master cell banks and/or working cell banksProbebetrieb bis: / valid until: 31.12.2026; Hersteller Arzneimittel: Novartis Pharmaceutical Manufacturing GmbH; Einschließlich Lagerung von Master- und/oder Working Cell Banks / including storage of master cell banks and/or working cell banksProbebetrieb bis: / valid until: 31.12.2026; Hersteller klinischer Prüfpräparate: Novartis Pharmaceutical Manufacturing GmbH; Einschließlich Lagerung von Master- und/oder Working Cell Banks / including storage of master cell banks and/or working cell banksProbebetrieb bis: / valid until: 31.12.2026;

Withdrawal comments in English: Superseded because new certificate was issued following an inspection

Withdrawal comments in National Language: Superseded because new certificate was issued following an inspection

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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.