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Austrian Agency For Health And Food Safety

CERTIFICATE NUMBER: 481921-104823957

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

The competent authority of Austria confirms the following:

The manufacturer: Sandoz GmbH

Site address:

Biochemiestrasse 10, Kundl, Tyrol, 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-A61-R2014/536/EU

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2025-11-27 , 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. 15 of Directive 2001/20/EC and Art. 80(5) of Directive 2001/82/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

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.4  Small volume liquids
           1.1.1.5  Solids and implants
   1.1.3  Batch certification

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
           1.2.1.6  Liquids for internal use
           1.2.1.8  Other solid dosage forms: Granulate zur Herstellung einer oralen Suspension / Granules for oral suspension, Granulate zur Herstellung einer oralen Lösung/ Granules for oral solution, Pulver zur Herstellung einer oralen Suspension/ Powder for oral suspension, Granulate zur Herstellung einer oralen Suspension / Granules for oral suspension, Granulate zur Herstellung einer oralen Lösung/ Granules for oral solution, Pulver zur Herstellung einer oralen Suspension/ Powder for oral suspension(en)
           1.2.1.13  Tablets
   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
           1.3.2.8  Other: Monoklonale Antikörper / Monoclonal antibodies, Monoklonale Antikörper / Monoclonal antibodies(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           1.5.1.6  Liquids for internal use
           1.5.1.8  Other solid dosage forms: Granulate zur Herstellung einer oralen Suspension / Granules for oral suspension, Granulate zur Herstellung einer oralen Lösung/ Granules for oral solution, Pulver zur Herstellung einer oralen Suspension/ Powder for oral suspension, Granulate zur Herstellung einer oralen Suspension / Granules for oral suspension, Granulate zur Herstellung einer oralen Lösung/ Granules for oral solution, Pulver zur Herstellung einer oralen Suspension/ Powder for oral suspension(en)
           1.5.1.13  Tablets
   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

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

2.2 Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
   2.2.2  Non-sterile products
   2.2.3  Biological medicinal products
           2.2.3.5  Biotechnology products
           2.2.3.8  Other: Monoklonale Antikörper / Monoclonal antibodies, Monoklonale Antikörper / Monoclonal antibodies(en)

2.3 Other importation activities

2.3.1 Site of physical importation
2.3.2 Importation of intermediate which undergoes further processing

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

[900000005460]Amoxicillin Trihydrate for Direct Compression I, Oral(en)

[900000005459]Penicillin V Potassium for Direct Compression, Oral(en)

[900000005461]Amoxicillin Trihydrate for Direct Compression, Oral(en)

[900000005468]Amoxicillin Trihydrate for Direct Compression II, Oral(en)

[900000005561]Amoxicillin trihydrate DC – Potassium Clavulanate, mixture 4:1(en)

[900000005558]Amoxicillin trihydrate – Potassium Clavulanate, mixture 2:1(en)

[900000005559]Amoxicillin trihydrate – Potassium Clavulanate, mixture 4:1(en)

[900000005560]Amoxicillin trihydrate – Potassium Clavulanate, mixture 7:1(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Amoxicillin Trihydrate for Direct Compression I, Oral

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Verwiegung / Weighing, Extrudierung / Extrusion, Trocknung / Drying, Siebung / Sieving, Mischen / M…

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:Penicillin V Potassium for Direct Compression, Oral

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Verwiegung / Weighing, Extrudierung / Extrusion, Trocknung / Drying, Siebung / Sieving, Mischen / M…

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:Amoxicillin Trihydrate for Direct Compression, Oral

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Verwiegung / Weighing, Extrudierung / Extrusion, Trocknung / Drying, Siebung / Sieving, Mischen / M…

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:Amoxicillin Trihydrate for Direct Compression II, Oral

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Verwiegung / Weighing, Extrudierung / Extrusion, Trocknung / Drying, Siebung / Sieving, Mischen / M…

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:Amoxicillin trihydrate DC – Potassium Clavulanate, mixture 4:1

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Siebung / Sieving, Mischen / Mixing

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:Amoxicillin trihydrate – Potassium Clavulanate, mixture 2:1

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Siebung / Sieving, Mischen / Mixing

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:Amoxicillin trihydrate – Potassium Clavulanate, mixture 4:1

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Siebung / Sieving, Mischen / Mixing

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:Amoxicillin trihydrate – Potassium Clavulanate, mixture 7:1

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Siebung / Sieving, Mischen / Mixing

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Clarifying remarks (for public users):

Hersteller Arzneimittel: Sandoz GmbH - Betriebsstätte / Manufacturing Site Anti Infectives & Chemical Operations FDF Kundl (AICO FDF Kundl); Diese Bewilligung umfasst für alle angeführten Arzneiformen den Einsatz von Penicillinen und Cephalosporinen. / The corresponding Author…; Hersteller klinischer Prüfpräparate: Sandoz GmbH - Betriebsstätte / Manufacturing Site Anti Infectives & Chemical Operations FDF Kundl (AICO FDF Kundl); Diese Bewilligung umfasst für alle angeführten Arzneiformen den Einsatz von Penicillinen und Cephalosporinen. / The corresponding Author…; Hersteller Wirkstoffe: Sandoz GmbH - Betriebsstätte / Manufacturing Site Anti Infectives & Chemical Operations FDF Kundl (AICO FDF Kundl); Probebetrieb betreffend folgende Verfahren bis zum 30.06.2028: / Regarding the following inspection cases valid until 30.06.2028: INS-48…;

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.