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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/158/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: Olon S.p.A.

Site address: Via Benvenuto Cellini 20, Segrate, 20054, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100012085 / LOC-100053001


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  2023-03-03 , 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:
    [0000000000348]AMIODARONE HYDROCHLORIDE(en)
    [00000000001693]FENOFIBRATE(en)
    [00000000008123]TRIFAROTENE(en)
    [000000000086]ETACRYNIC ACID(en)
    [00000000004122]THIOCTIC ACID(en)
    [00000000001369]DIHYDROERGOTAMINE MESYLATE(en)
    [00000000002020]GLICLAZIDE(en)
    [00000000004303]METHYL LEVODOPA HYDROCHLORIDE(en)
    [0000000000303]AMBROXOL THEOPHYLLINATE(en)
    [00000000001312]DICLOFENAC POTASSIUM(en)
    [00000000007427]FLUSPIRILENE(en)
    [00000000008081]LIFITEGRAST(en)
    [0000000000689]BUTAMIRATE CITRATE(en)
    [00000000004278]GABAPENTIN(en)
    [00000000005222]DICLOFENAC DIETHYLAMMONIUM(en)
    [00000000007880]TAVABOROLE(en)
    [00000000005812]ACAMPROSATE CALCIUM(en)
    [0000000000100007]UMECLIDINIO BROMURO(en)
    [00000000004164]CARISOPRODOL(en)
    [00000000001309]DICLOFENAC SODIUM(en)
    [00000000004373]PROPENTOFYLLINE(en)
    [00000000007030]CHOLINE FENOFIBRATE(en)
    [00000000007011]FLUPENTIXOL DECANOATE(en)
    [00000000007098]TIOTROPIUM BROMIDE MONOHYDRATE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

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

    Active Substance:FENOFIBRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    crystallisation
    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/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TRIFAROTENE
    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:
    crystallisation,purification,filtration
    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
     
    3.6.1  Physical / Chemical testing

    Active Substance:ETACRYNIC ACID
    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:
    crystallisation
    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/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:THIOCTIC ACID
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    crystallisation
    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, sieving, milling
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DIHYDROERGOTAMINE MESYLATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    purification
    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)

    Active Substance:GLICLAZIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    crystallisation
    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/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:METHYL LEVODOPA 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
     
    3.5.3  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, sieving, milling
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:AMBROXOL THEOPHYLLINATE
    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
     
    3.5.3  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
     
    3.6.1  Physical / Chemical testing

    Active Substance:DICLOFENAC POTASSIUM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    desalification, salt formation, crystallisation
    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, sieving, milling/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:LIFITEGRAST
    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
     
    3.5.3  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,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BUTAMIRATE CITRATE
    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
     
    3.5.3  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
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:GABAPENTIN
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    crystallisation
    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, sieving, milling/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DICLOFENAC DIETHYLAMMONIUM
    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:
    desalification, salt formation, crystallisation
    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, sieving, milling/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:ACAMPROSATE CALCIUM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    crystallisation
    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/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:UMECLIDINIO BROMURO
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    .
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    highly potent
    3.1.3  Salt formation / Purification steps:
    crystallisation,filtration,purification, dissolution
    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
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:DICLOFENAC SODIUM
    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
     
    3.5.3  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, sieving, milling/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:PROPENTOFYLLINE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    crystallisation
    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/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:CHOLINE FENOFIBRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    crystallisation
    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/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:FLUPENTIXOL DECANOATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    distillation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    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:TIOTROPIUM BROMIDE MONOHYDRATE
    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:
    crystallisation,salt formation
    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
     
    3.6.1  Physical / Chemical testing

    4. Other Activities - Active Substances:
    Importation of: THIOCTIC ACID CRUDE (confidential), HOMOTAURINE (confidential)

    Clarifying remarks (for public users):
    Manufactured active substances marked as confidential are for clinical use only. Imported APIs marked as confidential undergo further processing within the importing site: DIIDROERGOTAMINA MESILATO and (raw) LIRAGLUTIDE: no batch certification. According to Italian legislation, all the biological active substances and/or active substances deriving from human and animal tissues, organs, fluids are authorized according to art.40 of Dir. 2001/83/EC. On a risk-based approach, the validity of the GMP certificate for this manufacturing site is not more than 30 months from the latest general GMP inspection conducted on 2023/03/03, except for AIFA's re-evaluation of the risk profile.

     

     

    Withdrawal comments in English: withdraw certificate
    Withdrawal comments in National Language: certificato withdraw

    		 
    		 
     
         
     
     
    		 
     
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