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Ministry Of Health

CERTIFICATE NUMBER: NBF/28/2025/V

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

The competent authority of Italy confirms the following:

The manufacturer: Fresenius Kabi Ipsum S.r.l.

Site address: Via San Leonardo 23, Villadose, 45010, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100033448 / LOC-100053555


Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/60.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on  2025-09-04 , 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.
    		•

    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/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

    Veterinary Medicinal Products

    Manufacture of active substance. Names of substances subject to inspection:
    [11326]AMPICILLIN TRIHYDRATE STERILE(en)
    [13957]CEFALONIUM STERILE(en)
    [11330]CLOXACILLIN BENZATHINE STERILE(en)
    [11329]CLOXACILLIN SODIUM STERILE(en)
    [11332]OXACILLIN SODIUM STERILE(en)
    NAFCILLIN(en)
    AMPICILLIN SODIUM(en)
    CLOXACILLIN SODIUM(en)
    [15417]HETACILLIN POTASSIUM STERILE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:AMPICILLIN TRIHYDRATE STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, sieving, milling, mixing, micronisation
    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
    3.6.3  Microbiological testing including sterility testing
    3.6.4  Biological Testing
    Special Requirements:
    7.Other:
    LAL test

    Active Substance:CEFALONIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying,sieving, milling, mixing,micronisation
    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
    3.6.3  Microbiological testing including sterility testing
    3.6.4  Biological Testing
    Special Requirements:
    7.Other:
    LAL test

    Active Substance:CLOXACILLIN BENZATHINE STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    salt formation, crystallisation
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying,sieving, milling, mixing,micronisation
    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
    3.6.3  Microbiological testing including sterility testing
    3.6.4  Biological Testing
    Special Requirements:
    7.Other:
    LAL test

    Active Substance:CLOXACILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    salt formation, crystallisation
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, milling, sieving,mixing,micronisation
    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
    3.6.3  Microbiological testing including sterility testing
    3.6.4  Biological Testing
    Special Requirements:
    7.Other:
    LAL test

    Active Substance:OXACILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    salt formation, crystallisation
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, milling, sieving,mixing,micronisation
    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
    3.6.3  Microbiological testing including sterility testing
    3.6.4  Biological Testing
    Special Requirements:
    7.Other:
    LAL test

    Active Substance:NAFCILLIN
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, milling,sieving
    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
    3.6.4  Biological Testing
    Special Requirements:
    7.Other:
    LAL test

    Active Substance:AMPICILLIN SODIUM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallization
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, sieving, milling, mixing, micronization
    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
    3.6.3  Microbiological testing including sterility testing
    3.6.4  Biological Testing
    Special Requirements:
    7.Other:
    LAL test

    Active Substance:CLOXACILLIN SODIUM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    salt formation, crystallisation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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
    3.6.4  Biological Testing

    Active Substance:HETACILLIN POTASSIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    salt formation, crystallisation
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, sieving, milling, mixing, micronization
    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
    3.6.3  Microbiological testing including sterility testing
    3.6.4  Biological Testing
    Special Requirements:
    7.Other:
    LAL test

     

     


    		 
    		 
     
         
     
     
    		 
     
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