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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/8/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: Olon S.p.A.

Site address: Strada Provinciale Rivoltana Km 6-7, Rodano, 20053

OMS Organisation Id. / OMS Location Id.: ORG-100012085 / LOC-100019537


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  2024-10-16 , 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:
    [00000000007004]ABIRATERONE ACETATE(en)
    [00000000001025]CLOFARABINE(en)
    [00000000007177]POMALIDOMIDE(en)
    [00000000003386]RIFABUTIN(en)
    [00000000007176]TERIFLUNOMIDE(en)
    [00000000004556]ASENAPINE MALEATE(en)
    [00000000007018]BENDAMUSTINE HYDROCHLORIDE(en)
    [0000000000864]CEFAZOLIN SODIUM STERILE(en)
    [00000000005015]DEFEROXAMINE MESILATE STERILE(en)
    [00000000002130]IDARUBICIN HYDROCHLORIDE(en)
    [00000000008125]ONCOFID P-20(en)
    [00000000003070]PERGOLIDE MESYLATE(en)
    [00000000003400]RITONAVIR(en)
    [00000000001669]FENFLURAMINA CLORIDRATO(en)
    [00000000004221]ROTIGOTINE HYDROCHLORIDE(en)
    [0000000000696]CABERGOLINE(en)
    [00000000004203]CLOBENZOREX HYDROCHLORIDE(en)
    [00000000007855]LENVATINIB MESYLATE(en)
    [00000000008004]OPICAPONE(en)
    [00000000007684]ETHYL ACETATE SOLUTION OF PURIFIED ISOMERISED TAMOXIFEN BASE(en)
    [0000000000433]ATAZANAVIR SULFATE(en)
    [00000000007923]CANGRELOR TETRASODIUM CRUDE(en)
    [0000000000863]CEFAZOLIN ACID(en)
    [00000000001369]DIHYDROERGOTAMINE MESYLATE(en)
    [00000000007683]TOFACITINIB CITRATE(en)
    [00000000004190]CEFTOBIPROLE MEDOCARIL(en)
    [00000000004647]LYMECYCLINE(en)
    [00000000002604]METERGOLINE(en)
    [00000000002728]MORCLOFONE(en)
    [00000000002807]NICERGOLINE(en)
    [00000000007095]D,L CLOBENZOREX(en)
    [00000000001200]DEFEROXAMINE MESILATE(en)
    [00000000002313]IRINOTECAN HYDROCHLORIDE TRIHYDRATE(en)
    [00000000003347]RALOXIFENE HYDROCHLORIDE(en)
    [00000000005736]ROTIGOTINE(en)
    [00000000004122]THIOCTIC ACID(en)
    [0000000000179]ACIPIMOX(en)
    [00000000002024]GLIPIZIDE(en)
    [00000000002226]INDOBUFEN(en)
    [00000000002506]MELPHALAN HYDROCHLORIDE(en)
    [00000000004014]VALGANCICLOVIR HYDROCHLORIDE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:ABIRATERONE ACETATE
    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
    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

    Active Substance:CLOFARABINE
    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:
    7.Other:
    Other: Cytotoxic
    3.1.2  Manufacture of crude active substance
    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
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:POMALIDOMIDE
    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:
    7.Other:
    Other: Cytotoxic
    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,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:RIFABUTIN
    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
    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:TERIFLUNOMIDE
    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
    3.5 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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:ASENAPINE MALEATE
    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
    3.1.2  Manufacture of crude active substance
    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

    Active Substance:BENDAMUSTINE 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:
    7.Other:
    Other: Cytotoxic
    3.1.2  Manufacture of crude active substance
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, hydratation
    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:CEFAZOLIN SODIUM STERILE
    3.5 General Finishing Steps
     
    3.5.4  Other:
    batch certification
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    Special Requirements:
    1.B-lactam antibiotics
    3.6.4  Biological Testing

    Active Substance:DEFEROXAMINE MESILATE STERILE
    3.5 General Finishing Steps
     
    3.5.4  Other:
    batch certification
    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

    Active Substance:IDARUBICIN HYDROCHLORIDE
    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:
    7.Other:
    Other: Cytotoxic
    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
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:ONCOFID P-20
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation,filtration
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Cytotoxic
    3.1.2  Manufacture of crude active substance
    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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:PERGOLIDE MESYLATE
    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:
    purification,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

    Active Substance:RITONAVIR
    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,sieving,mixing
    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:FENFLURAMINA CLORIDRATO
    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:ROTIGOTINE HYDROCHLORIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    purification
    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
    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:CABERGOLINE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    purification,chromatography,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,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:CLOBENZOREX 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
    3.1.2  Manufacture of crude active substance
    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

    Active Substance:LENVATINIB MESYLATE
    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
    Special Requirements:
    7.Other:
    Other: Cytotoxic
    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,hydration,milling/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:OPICAPONE
    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
    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

    Active Substance:ETHYL ACETATE SOLUTION OF PURIFIED ISOMERISED TAMOXIFEN BASE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation,filtration
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ATAZANAVIR SULFATE
    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
    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

    Active Substance:CANGRELOR TETRASODIUM CRUDE
    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
    3.5 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

    Active Substance:CEFAZOLIN ACID
    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:
    salt formation,purification,crystallisation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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:DIHYDROERGOTAMINE MESYLATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation,salt formation
    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
    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:TOFACITINIB CITRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation,salt formation
    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
    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

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

    Active Substance:LYMECYCLINE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    purification
    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
    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:METERGOLINE
    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
    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,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:MORCLOFONE
    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:
    purification,crystallisation
    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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:NICERGOLINE
    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
    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:D,L CLOBENZOREX
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    precipitation, concentration
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DEFEROXAMINE MESILATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.1.2  Manufacture of crude active substance
    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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:IRINOTECAN HYDROCHLORIDE TRIHYDRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Cytotoxic
    3.1.3  Salt formation / Purification steps:
    purification,crystallisation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, hydratation
    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:RALOXIFENE HYDROCHLORIDE
    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:
    purification,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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:ROTIGOTINE
    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:
    purification,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

    Active Substance:THIOCTIC ACID
    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:
    purification,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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:ACIPIMOX
    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:
    purification,crystallisation
    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,mixing
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:GLIPIZIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    salt formation,purification
    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,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:INDOBUFEN
    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:
    purification,crystallisation
    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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:MELPHALAN HYDROCHLORIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Cytotoxic
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    salt formation,purification,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
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:VALGANCICLOVIR 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
    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

    4. Other Activities - Active Substances:
    Importation of: 7-ETHYL-10-HYDROXY-CAMPTOTHECIN (confidential), PRASTERONE (confidential), TETRACYCLINE HYDROCHLORIDE (confidential)

    Clarifying remarks (for public users):
    According to Italian legislation, sterile active substances (AS) are authorized according to art. 40 of Dir. 2001/83/EC and the sterilization process is performed in accordance with the EU-GMP, including its Annex 1, as laid down in Dir. 2003/94/EC. Deferoxamine Mesilate sterile: aseptic lyophilization outsourced. Manufactured AS marked as confidential are for clinical use only. Imported AS marked as confidential undergo further processing within the importing site. 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 2022/07/22, except for AIFA's re-evaluation of the risk profile.

     

     


    		 
    		 
     
         
     
     
    		 
     
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