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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/181/H/2024

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: F.I.S. Fabbrica Italiana Sintetici S.p.A.

Site address: Via Massimo D' Antona 13, Termoli, 86039, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100011866 / LOC-100021145


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  2023-09-22 , 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:
    [00000000008066]DIAZEPINONE N-OXIDE(en)
    [00000000005658]EMPAGLIFLOZIN(en)
    [00000000001627]ETORICOXIB(en)
    [00000000005831]RANOLAZINE(en)
    [0000000000764]CARBAMAZEPINE(en)
    [00000000002228]INDOMETACIN(en)
    [00000000002678]MYCOPHENOLATE MOFETIL(en)
    [00000000004104]SITAGLIPTIN PHOSPHATE MONOHYDRATE(en)
    [00000000004267]PHLOROGLUCINOL DIHYDRATE(en)
    [00000000002922]OXCARBAZEPINE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:DIAZEPINONE N-OXIDE
    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
    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/micronisation,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:EMPAGLIFLOZIN
    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
    3.1.2  Manufacture of crude active substance
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying,milling
    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:ETORICOXIB
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    desalification,crystallisation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, 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

    Active Substance:RANOLAZINE
    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
    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/micronisation,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:CARBAMAZEPINE
    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
    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, sieving/milling
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:INDOMETACIN
    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
    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/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:MYCOPHENOLATE MOFETIL
    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
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying,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:SITAGLIPTIN PHOSPHATE MONOHYDRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying,milling,micronisation,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:PHLOROGLUCINOL DIHYDRATE
    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
    3.1.2  Manufacture of crude active substance
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying,milling
    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:OXCARBAZEPINE
    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
    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/micronisation,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    4. Other Activities - Active Substances:
    Importation of: MYCOPHENOLIC ACID (confidential), D, L - SERINE (confidential)

    Clarifying remarks (for public users):
    Imported active substances marked as confidential undergo further processing within the importing site. The active substance Diazepinone N-oxide is released for further processing to other sister companies. On a risk-based approach, the validity of the GMP certificate for this manufacturing site is not more than 42 months from the latest general GMP inspection conducted on 2023/09/22, except for AIFA's re-evaluation of the riskprofile.

     

     


    		 
    		 
     
         
     
     
    		 
     
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