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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/37/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: Indena S.p.A.

Site address: Via Don Minzoni 6, Settala, 20049, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100006081 / LOC-100010689


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  2023-10-20 , 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:
    [00000000004248]ENOXOLONE(en)
    [00000000007346]THIOCOLCHICOSIDE (SEMI-SYNTETHIC)(en)
    [00000000008788]TIRBANIBULIN(en)
    [0000000000625]BOLDINE(en)
    [0000000000790]MILK THISTLE FRUIT (Silybum Marianum L.GAERTNER) DRY EXTRACT(en)
    [0000000000797]CARMUSTINE(en)
    [00000000001142]COLCHICINE(en)
    [00000000007702]DOCETAXEL TRIHYDRATE(en)
    [00000000007331]PANAX GINSENG ROOT (Panax Ginseng C.A. Meyer) DRY EXTRACT(en)
    [10000000004971]ACTIVE SUBSTANCES (NON STERILE AND/OR NON BIOLOGICAL, NON FROM HUMAN AND ANIMAL TISSUES, ORGANS, FLUIDS)(en)
    [00000000004440]BILBERRY FRESH FRUIT (Vaccinium myrtillus L.) DRY EXTRACT STANDARDISED (Ph. Eur.)(en)
    [00000000003052]PENTOSAN POLYSULFATE SODIUM(en)
    [00000000007212]ST. JOHN''S WORT FLOWERING TOPS (Hypericum perforatum L.) QUANTIFIED DRY EXTRACT(en)
    [00000000007332]PACLITAXEL FROM WHOLE PLANT(en)
    [00000000007349]PRUNUS AFRICANA BARK(Prunus africana (Hook.f.) Kalkman) SOFT EXTRACT CRUDE(en)
    [00000000007118]ROMIDEPSINA(en)
    [00000000004384]RUSCOGENINS(en)
    [00000000006163]CABAZITAXEL(en)
    [00000000008722]CANNABIDIOL (BY EXTRACTION)(en)
    [00000000001418]DOCETAXEL(en)
    [00000000007335]GALANTHAMINE HYDROBROMIDE(en)
    [00000000007345]PACLITAXEL (SEMI-SYNTHETIC)(en)
    [00000000007347]THIOCOLCHICOSIDE (BY FERMENTATION)(en)
    [0000000000100742]CROFELEMER(en)
    [00000000003368]RESERPINE(en)
    [00000000007336]BETA-ESCIN (Aesculus hippocastanum L., seed) DRY EXTRACT REFINED(en)
    [00000000004191]TRITERPENIC MIX FROM CENTELLA ASIATICA LEAF (Centella asiatica (L.) Urban)(en)
    [00000000007354]SAW PALMETTO FRUIT (Serenoa repens (W. Bartram) Small) soft extract(en)
    [00000000003795]THIOTEPA(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:ENOXOLONE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.5  Modification of extracted substance Plant 
    3.2.7  Other:
    plant source: Glycyrrhiza glabra, root
    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
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:THIOCOLCHICOSIDE (SEMI-SYNTETHIC)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.5  Modification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    3.2.7  Other:
    plant source: Gloriosa superba, seed
    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:TIRBANIBULIN
    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:
    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:BOLDINE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    3.2.7  Other:
    plant source: Peumus boldus Molina, bark
    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

    Active Substance:MILK THISTLE FRUIT (Silybum Marianum L.GAERTNER) DRY EXTRACT
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    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, blending
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:CARMUSTINE
    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: Cytotoxic
    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:COLCHICINE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    3.2.7  Other:
    plant source: Gloriosa superba, seed
    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

    Active Substance:DOCETAXEL TRIHYDRATE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.5  Modification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    Special Requirements:
    7.Other:
    Other: Cytotoxic
    3.2.7  Other:
    plant source: Taxus Baccata, leaves and twigs
    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
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:PANAX GINSENG ROOT (Panax Ginseng C.A. Meyer) DRY EXTRACT
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    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,sieving
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

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

    Active Substance:BILBERRY FRESH FRUIT (Vaccinium myrtillus L.) DRY EXTRACT STANDARDISED (Ph. Eur.)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    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,standardisation,sieving
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:PENTOSAN POLYSULFATE SODIUM
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.5  Modification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    3.2.7  Other:
    Fagus Sylvatica L., tree log
    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

    Active Substance:ST. JOHN''S WORT FLOWERING TOPS (Hypericum perforatum L.) QUANTIFIED DRY EXTRACT
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    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, quantification, sieving
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:PACLITAXEL FROM WHOLE PLANT
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    Special Requirements:
    7.Other:
    Other: Cytotoxic
    3.2.7  Other:
    plant source: Taxus xmedia rehder, roots, leaves and twigs
    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

    Active Substance:PRUNUS AFRICANA BARK(Prunus africana (Hook.f.) Kalkman) SOFT EXTRACT CRUDE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    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:
    solvent evaporation
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:ROMIDEPSINA
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.3  Isolation / Purification
    3.3.1  Fermentation
    Special Requirements:
    7.Other:
    Other: Cytotoxic
    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:RUSCOGENINS
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.5  Modification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    3.2.7  Other:
    plant source: Ruscus aculeatus L., rhyzome and root
    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
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:CABAZITAXEL
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.5  Modification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    3.2.7  Other:
    Taxus baccata, leaves and twigs
    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:CANNABIDIOL (BY EXTRACTION)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.5  Modification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    3.2.7  Other:
    Cannabis sativa L., inflorescences, leaves and twigs
    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

    Active Substance:DOCETAXEL
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.5  Modification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    Special Requirements:
    7.Other:
    Other: Cytotoxic
    3.2.7  Other:
    plant source: Taxus Baccata, leaves and twigs
    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
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:GALANTHAMINE HYDROBROMIDE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.5  Modification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    3.2.7  Other:
    plant source: Narcisus pseudonarciissus L., bulb
    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,sieving
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:PACLITAXEL (SEMI-SYNTHETIC)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.5  Modification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    Special Requirements:
    7.Other:
    Other: Cytotoxic
    3.2.7  Other:
    plant source: Taxus Baccata, leaves and twigs; Taxus wallichiana var. Mairei, leaves and twigs
    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:THIOCOLCHICOSIDE (BY FERMENTATION)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.5  Modification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    3.2.7  Other:
    plant source: Gloriosa superba, seed
    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
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:CROFELEMER
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    3.2.7  Other:
    Croton lechleri Mull.Arg., latex
    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

    Active Substance:RESERPINE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    3.2.7  Other:
    plant source: Rauvolfia vomitoria Afzel, root bark
    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

    Active Substance:BETA-ESCIN (Aesculus hippocastanum L., seed) DRY EXTRACT REFINED
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    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:
    crystallisation/spray drying, drying, sieving
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:TRITERPENIC MIX FROM CENTELLA ASIATICA LEAF (Centella asiatica (L.) Urban)
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Plant 
    3.2.5  Modification of extracted substance Plant 
    3.2.1  Extraction of substance from plant source
    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,mixing,sieving
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:SAW PALMETTO FRUIT (Serenoa repens (W. Bartram) Small) soft extract
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    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:
    solvent evaporation
    3.6 Quality Control Testing
     
    3.6.2  Microbiological testing excluding sterility testing
    3.6.1  Physical / Chemical testing

    Active Substance:THIOTEPA
    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: Cytotoxic
    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

    4. Other Activities - Active Substances:
    Importation of: CENTELLA ASIATICA LEAF (Centella asiatica (L.), Urban) INTERMEDIATE EXTRACT (confidential), CRUDE COLCHICINA (confidential), THIOCOLCHICOSIDE (SEMI-SYNTETHIC)

    Clarifying remarks (for public users):
    Imported active substances (AS) marked as confidential undergo further processing within the importing site. Manufactured AS marked as confidential are for clinical use only. The active substances can be manufactured at different concentrations and using different extraction solvents. 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 2023/10/20, except for AIFA's re-evaluation of the risk profile.

     

     


    		 
    		 
     
         
     
     
    		 
     
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