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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/20/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: Curia Italy S.r.l.

Site address: Via Volturno 41/43, Rozzano, 20089, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100032082 / LOC-100050148


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  2023-05-25 , 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:
    [00000000001365]DIHYDROERGOCRISTINE MESYLATE(en)
    [00000000007370]THIOCOLCHICOSIDE CRUDE (BY FERMENTATION)(en)
    [00000000002969]PANCURONIUM BROMIDE(en)
    [00000000003406]ROCURONIUM BROMIDE(en)
    [00000000003507]SIROLIMUS(en)
    [00000000005653]ARGATROBAN(en)
    [0000000000652]BROMOCRIPTINE MESYLATE(en)
    [00000000004025]VECURONIUM BROMIDE(en)
    [0000000000967]CICLOSPORIN(en)
    [00000000001362]DIHYDROERGOCRYPTINE MESYLATE(en)
    [00000000001369]DIHYDROERGOTAMINE MESYLATE(en)
    [00000000002535]MEDROGESTONE(en)
    [00000000001533]ERGOTAMINE TARTRATE(en)
    [0000000000455]AZELASTINE HYDROCHLORIDE(en)
    [0000000000962]CYCLOFENIL(en)
    [00000000001255]DESOGESTREL(en)
    [00000000002918]OXANDROLONE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:DIHYDROERGOCRISTINE MESYLATE
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.4  Modification
    3.3.3  Isolation / Purification
    3.3.1  Fermentation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:THIOCOLCHICOSIDE CRUDE (BY FERMENTATION)
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.5  Other:
    plant source: Gloriosa superba, seed
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:PANCURONIUM BROMIDE
    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
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:ROCURONIUM BROMIDE
    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
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:SIROLIMUS
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.3  Isolation / Purification
    3.3.1  Fermentation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:ARGATROBAN
    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
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:BROMOCRIPTINE MESYLATE
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.4  Modification
    3.3.3  Isolation / Purification
    3.3.1  Fermentation
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying, granulation,micronisation
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:VECURONIUM BROMIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:CICLOSPORIN
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.3  Isolation / Purification
    3.3.1  Fermentation
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying, granulation
    3.6 Quality Control Testing
     
    3.6.4  Biological Testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:DIHYDROERGOCRYPTINE MESYLATE
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.4  Modification
    3.3.3  Isolation / Purification
    3.3.1  Fermentation
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying, granulation
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:DIHYDROERGOTAMINE MESYLATE
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.4  Modification
    3.3.3  Isolation / Purification
    3.3.1  Fermentation
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying, granulation
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:MEDROGESTONE
    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
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:ERGOTAMINE TARTRATE
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.5  Other:
    salt formation
    3.3.3  Isolation / Purification
    3.3.1  Fermentation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:AZELASTINE HYDROCHLORIDE
    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
    3.5.3  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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:CYCLOFENIL
    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
     
    3.5.3  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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:DESOGESTREL
    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
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:OXANDROLONE
    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
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    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)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,milling
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    4. Other Activities - Active Substances:
    Importation of: 17alfa-METHYL-3-ETHOXY-3,5-PREGNADEN-20-ONE (confidential), EPIANDROSTERONE (confidential)

    Clarifying remarks (for public users):
    Imported active substances (AS) marked as confidential undergo further processing within the importing site and/or are released to other AS manufacturing sites for further processing. 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 2022/09/16, except for AIFA's re-evaluation of the risk profile.

     

     


    		 
    		 
     
         
     
     
    		 
     
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