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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/102/H/2026

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

The competent authority of Italy confirms the following:

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

Site address: Via San Leonardo 23, Villadose, 45010

OMS Organisation Id. / OMS Location Id.: ORG-100015105 / LOC-100023792


Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC0.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on  2026-05-08 , it is considered that it complies with:

  • The principles of GMP for active substances referred to in 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.
    		•

    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/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

    Manufacture of active substance. Names of substances subject to inspection:
    [000000000370]AMOXICILLIN SODIUM STERILE(en)
    [000000000379]AMPICILLIN SODIUM STERILE(en)
    [000000000462]BACAMPICILLIN HYDROCHLORIDE(en)
    [0000000004563]BENZYLPENICILLIN SODIUM STERILE(en)
    [0000000001113]CLOXACILLIN SODIUM(en)
    [0000000001118]CLOXACILLIN SODIUM STERILE(en)
    [0000000001331]DICLOXACILLIN SODIUM(en)
    [0000000001794]FLUCLOXACILLIN SODIUM(en)
    [0000000001798]FLUCLOXACILLIN SODIUM STERILE(en)
    [0000000005986]MECILLINAM STERILE(en)
    [0000000006174]NAFCILLIN(en)
    [0000000004323]NAFCILLIN SODIUM STERILE(en)
    [0000000002915]OXACILLIN SODIUM STERILE(en)
    [0000000003113]PIPERACILLIN(en)
    [0000000004365]PIVMECILLINAM HYDROCHLORIDE(en)
    [0000000004401]SULBACTAM SODIUM STERILE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:AMOXICILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Crystallization, Salt formation
    Special Requirements:
    1.B-lactam antibiotics
    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
    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

    Active Substance:AMPICILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Crystallization, Salt formation
    Special Requirements:
    1.B-lactam antibiotics
    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
    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

    Active Substance:BACAMPICILLIN HYDROCHLORIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, milling, Sieving, Compacting
    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

    Active Substance:BENZYLPENICILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Crystallization, Salt formation
    Special Requirements:
    1.B-lactam antibiotics
    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
    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

    Active Substance:CLOXACILLIN SODIUM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization, Salt formation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, milling, Sieving, 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
    3.6.4  Biological Testing

    Active Substance:CLOXACILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization, Salt formation
    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, 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

    Active Substance:DICLOXACILLIN SODIUM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization, Salt formation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, milling, Sieving, Compacting
    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

    Active Substance:FLUCLOXACILLIN SODIUM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization, Salt formation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, milling, Sieving, Compacting
    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

    Active Substance:FLUCLOXACILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization, Salt formation
    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
    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:
    Batch certification
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.3  Microbiological testing including sterility testing
    3.6.4  Biological Testing

    Active Substance:MECILLINAM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    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, 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
    3.6.3  Microbiological testing including sterility testing
    3.6.4  Biological Testing

    Active Substance:NAFCILLIN
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    1.B-lactam antibiotics
    3.1.3  Salt formation / Purification steps:
    Crystallization
    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

    Active Substance:NAFCILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    1.B-lactam antibiotics
    3.1.3  Salt formation / Purification steps:
    Crystallization, Salt formation
    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
    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

    Active Substance:OXACILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization, Salt formation
    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, 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

    Active Substance:PIPERACILLIN
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    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
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:PIVMECILLINAM HYDROCHLORIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    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

    Active Substance:SULBACTAM SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization, Salt formation
    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
    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

    4. Other Activities - Active Substances:
    Importation of: AMOXICILLIN TRIHYDRATE (confidential), SULBACTAM (confidential), BENZYLPENICILLIN POTASSIUM (confidential), PIPERACILLIN (confidential), TAZOBACTAM (confidential), AMPICILLIN TRIHYDRATE (confidential)

    Clarifying remarks (for public users):
    Imported active substances (AS) marked as confidential are used for manufacturing AS and medicinal products within the importing site and/or released to other manufacturing sites. Importation of AS used for manufacturing medicinal products falls under the responsibility of the QP/QPs listed in the MIA. Batch certification of AS Ampicillin sodium sterile manufactured by third part. According to Italian legislation, sterile AS are authorized according to art. 40 of Dir.2001/83/EC and the aseptic processing is performed in accordance with the EU-GMP, including its Annex 1, as laid down in Dir. 2003/94/EC. On a risk-based approach, the validity of the GMP certificate for this manufacturing site is not more than 36 months from the latest general GMP inspection conducted on 2026/05/08, except for AIFA's re-evaluation of the risk profile.

     

     


    		 
    		 
     
         
     
     
    		 
     
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