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State Institute For Drug Control

CERTIFICATE NUMBER: sukls69551/2024

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 CZECHIA confirms the following:

The manufacturer: Teva Czech Industries s.r.o.

Site address: Ostravska 305/29, Komarov, 747 70, CZECHIA

OMS Organisation Id. / OMS Location Id.: ORG-100000320 / LOC-100002065


Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:Section 101 paragraph 3 of the Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on  2024-05-16 , 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 transposed in the following national legislation:Section 101 paragraph 3 of the Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended.
    		•

    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:
    [10960]ANASTROZOLE CAS 120511-73-1(en)
    [416873697]BORTEZOMIB ANHYDRIDE CAS 390800-88-1(en)
    [718768]BROMOCRIPTINE MESILATE 22260-51-1(en)
    [11342]BUPRENORPHINE HYDROCHLORIDE CAS 53152-21-9(en)
    [11343]BUPRENORPHINE CAS 52485-79-7(en)
    [11344]BUTORPHANOL TARTRATE CAS 58786-99-5(en)
    [4168736975649]CABAZITAXEL 2-PROPANOL CAS 1402820-62-5(en)
    [11346]CABERGOLINE CAS 81409-90-7(en)
    [718770125225]CICLOSPORIN CAS 59865-13-3(en)
    [11350]DIHYDROERGOTAMINE MESILATE CAS 6190-39-2(en)
    [11351]DIHYDROERGOTOXINE MESILATE CAS 8067-24-1(en)
    [11352]ERGOMETRINE MALEATE CAS 129-51-1(en)
    [71877012525666]ERGOTAMINE TARTRATE CAS 379-79-3(en)
    [15003]CURCUMIN DRY EXTRACT(en)
    [15004]FRANGULA EMODIN(en)
    [71871487633]NOVO-PASSIT LIQUID EXTRACT(en)
    [76178962187]NOVO-PASSIT DRY EXTRACT(en)
    [15008]LIQUORICE LIQUID EXTRACT(en)
    [5419687503]PLANTAGINACEAE LIQUID EXTRACT(en)
    [15005]WILD THYME LIQUID EXTRACT(en)
    [15006]THYME LIQUID EXTRACT(en)
    [413]FINGOLIMOD HYDROCHLORIDE CAS 162359-55-9(en)
    [11356]GALANTAMINE HYDROBROMIDE CAS 1953-04-4(en)
    [187688888888]GLATIRAMER ACETATE CAS 147245-92-9(en)
    [45617788]METOPIMAZINE CAS 14008-44-7(en)
    [4158468716]METHYLERGOMETRINE HYDROGENOMALEATE CAS 57432-61-8(en)
    [187688845]MICAFUNGIN SODIUM CAS 208538-73-2(en)
    [11363]MYCOPHENOLATE MOFETIL CAS 115007-34-6(en)
    [11364]NICERGOLINE CAS 27848-84-6(en)
    [11365]PACLITAXEL CAS 33069-62-4(en)
    [13193]PALONOSETRON HYDROCHLORIDE CAS 135729-62-3(en)
    [45617793]PEMETREXED DISODIUM HEMIPENTAHYDRATE CAS 357166-30-4(en)
    [45617794]PERAMPANEL CAS 380917-97-5(en)
    [187688847]PERGOLIDE MESILATE CAS 66104-23-2(en)
    [41687341406]MILK THISTLE DRY EXTRACT (SILYMARIN), REFINED AND STANDARDISED CAS 65666-07-1(en)
    [187688848]TACROLIMUS MONOHYDRATE CAS 109581-93-3(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:ANASTROZOLE CAS 120511-73-1
    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:
    crystallisation, extraction
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, micronisation
    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:BORTEZOMIB ANHYDRIDE CAS 390800-88-1
    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:
    filtration, 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:BROMOCRIPTINE MESILATE 22260-51-1
    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:
    filtration, crystallisation
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, milling / micronisation
    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:BUPRENORPHINE HYDROCHLORIDE CAS 53152-21-9
    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:
    filtration, crystallisation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, sieving, milling, micronisation
    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:BUPRENORPHINE CAS 52485-79-7
    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:
    extraction, filtration, 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:BUTORPHANOL TARTRATE CAS 58786-99-5
    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:
    crystallisation, filtration
    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

    Active Substance:CABAZITAXEL 2-PROPANOL CAS 1402820-62-5
    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:
    filtration, 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:CABERGOLINE CAS 81409-90-7
    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:
    filtration, crystallisation
    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

    Active Substance:CICLOSPORIN CAS 59865-13-3
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.3  Isolation / Purification
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, sieving, homogenisation
    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:DIHYDROERGOTAMINE MESILATE CAS 6190-39-2
    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:
    filtration, crystallisation
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.5 General Finishing Steps
     
    3.5.1  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:DIHYDROERGOTOXINE MESILATE CAS 8067-24-1
    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:
    filtration, crystallisation
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    homogenisation, 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

    Active Substance:ERGOMETRINE MALEATE CAS 129-51-1
    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:
    filtration, crystallisation
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.5 General Finishing Steps
     
    3.5.1  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:ERGOTAMINE TARTRATE CAS 379-79-3
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.2.7  Other:
    salt formation
    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:CURCUMIN DRY EXTRACT
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:FRANGULA EMODIN
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.5  Modification of extracted substance Plant 
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    homogenisation, 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

    Active Substance:NOVO-PASSIT LIQUID EXTRACT
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    homogenization
    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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:NOVO-PASSIT DRY EXTRACT
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    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:LIQUORICE LIQUID EXTRACT
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    sedimentation, filtration, homogenization
    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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:PLANTAGINACEAE LIQUID EXTRACT
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    sedimentation, filtration, homogenization
    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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:WILD THYME LIQUID EXTRACT
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    sedimentation, filtration, homogenization
    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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:THYME LIQUID EXTRACT
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    sedimentation, filtration, homogenization
    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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:FINGOLIMOD HYDROCHLORIDE CAS 162359-55-9
    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:
    crystallisation, filtration
    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

    Active Substance:GALANTAMINE HYDROBROMIDE CAS 1953-04-4
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.2.7  Other:
    salt formation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, sieving, milling/micronisation
    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:GLATIRAMER ACETATE CAS 147245-92-9
    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:
    filtration
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophilisation
    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:METOPIMAZINE CAS 14008-44-7
    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:
    filtration, 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:METHYLERGOMETRINE HYDROGENOMALEATE CAS 57432-61-8
    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:
    filtration, crystallisation
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    milling, 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:MICAFUNGIN SODIUM CAS 208538-73-2
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    chromatography
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophylisation
    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:MYCOPHENOLATE MOFETIL CAS 115007-34-6
    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
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.3  Isolation / Purification
    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

    Active Substance:NICERGOLINE CAS 27848-84-6
    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:
    filtration, extraction, crystallisation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    milling, 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:PACLITAXEL CAS 33069-62-4
    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:
    filtration, chromatography, 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:PALONOSETRON HYDROCHLORIDE CAS 135729-62-3
    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:
    crystallisation, filtration
    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:PEMETREXED DISODIUM HEMIPENTAHYDRATE CAS 357166-30-4
    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:
    filtration, 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:PERAMPANEL CAS 380917-97-5
    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:
    filtration, crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, sieving, micronisation
    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 MESILATE CAS 66104-23-2
    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:
    crystallisation, filtration
    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

    Active Substance:MILK THISTLE DRY EXTRACT (SILYMARIN), REFINED AND STANDARDISED CAS 65666-07-1
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, milling, 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

    Active Substance:TACROLIMUS MONOHYDRATE CAS 109581-93-3
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.3  Isolation / Purification
    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

     

     


    		 
    		 
     
         
     
     
    		 
     
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