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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/9/H/2025bis

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  2024-02-23 , 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:
    [00000000004186]CEFOTAXIME SODIUM STERILE(en)
    [0000000000915]CEFUROXIME SODIUM STERILE(en)
    [00000000002915]OXACILLIN SODIUM STERILE(en)
    [0000000000462]BACAMPICILLIN HYDROCHLORIDE(en)
    [0000000000911]CEFTRIAXONE SODIUM STERILE(en)
    [00000000006174]NAFCILLIN(en)
    [10000000004796]ACTIVE SUBSTANCES (STERILE AND/OR BIOLOGICAL AND/OR FROM HUMAN AND ANIMAL TISSUES, ORGANS, FLUIDS)(en)
    [0000000000379]AMPICILLIN SODIUM STERILE(en)
    [0000000000868]CEFEPIME HYDROCHLORIDE STERILE(en)
    [00000000001118]CLOXACILLIN SODIUM STERILE(en)
    [00000000003113]PIPERACILLIN(en)
    [00000000005986]MECILLINAM STERILE(en)
    [00000000004563]BENZYLPENICILLIN SODIUM STERILE(en)
    [0000000000903]CEFTAZIDIME STERILE(en)
    [00000000001331]DICLOXACILLIN SODIUM(en)
    [0000000000370]AMOXICILLIN SODIUM STERILE(en)
    [00000000001794]FLUCLOXACILLIN SODIUM(en)
    [00000000001798]FLUCLOXACILLIN SODIUM STERILE(en)
    [00000000004401]SULBACTAM SODIUM STERILE(en)
    [00000000001113]CLOXACILLIN SODIUM(en)
    [00000000004323]NAFCILLIN SODIUM STERILE(en)
    [00000000004365]PIVMECILLINAM HYDROCHLORIDE(en)
    [00000000005767]TAZOBACTAM(en)
    [10000000004971]ACTIVE SUBSTANCES (NON STERILE AND/OR NON BIOLOGICAL, NON FROM HUMAN AND ANIMAL TISSUES, ORGANS, FLUIDS)(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:CEFOTAXIME SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.2  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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    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:CEFUROXIME SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.2  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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.1  Physical / Chemical testing
    3.6.3  Microbiological testing including sterility testing

    Active Substance:OXACILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    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)
    3.5.1  Physical processing steps:
    drying,milling,sieving,micronisation
    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
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    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:CEFTRIAXONE SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.2  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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    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
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    1.B-lactam antibiotics
    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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.4  Biological Testing

    Active Substance:ACTIVE SUBSTANCES (STERILE AND/OR BIOLOGICAL AND/OR FROM HUMAN AND ANIMAL TISSUES, ORGANS, FLUIDS)
    3.5 General Finishing Steps
     
    3.5.4  Other:
    storage

    Active Substance:AMPICILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.2  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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    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:CEFEPIME HYDROCHLORIDE STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.2  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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    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 STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    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,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

    Active Substance:PIPERACILLIN
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    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:MECILLINAM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    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:BENZYLPENICILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    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:CEFTAZIDIME STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.2  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)
    3.5.1  Physical processing steps:
    drying,sieving,milling
    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
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    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:AMOXICILLIN SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.2  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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    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:FLUCLOXACILLIN SODIUM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    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
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    Special Requirements:
    1.B-lactam antibiotics
    3.5 General Finishing Steps
     
    3.5.4  Other:
    batch certification
    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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    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:SULBACTAM SODIUM STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    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)
    3.5.1  Physical processing steps:
    drying,sieving,milling
    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
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    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)
    3.5.1  Physical processing steps:
    drying,milling,sieving,micronisation
    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
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    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:PIVMECILLINAM HYDROCHLORIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TAZOBACTAM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    1.B-lactam antibiotics
    3.1.2  Manufacture of crude active substance
    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)
    3.5.1  Physical processing steps:
    drying,milling,sieving
    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:ACTIVE SUBSTANCES (NON STERILE AND/OR NON BIOLOGICAL, NON FROM HUMAN AND ANIMAL TISSUES, ORGANS, FLUIDS)
    3.5 General Finishing Steps
     
    3.5.4  Other:
    storage

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

    Clarifying remarks (for public users):
    Imported active substances (AS) marked as confidential are used for manufacturing AS andmedicinal products within the importing site and/or released to other manufacturing sites.Importation of AS used for manufacturing medicinal products falls under the responsibilityof the QP/QPs listed in the MIA. 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 17 months from the latest general GMP inspection conducted on 2024/02/23, except for AIFA's re-evaluation of the risk profile.

     

     


    		 
    		 
     
         
     
     
    		 
     
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