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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/155/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: Cambrex Profarmaco Milano S.r.l.

Site address: Via Eugenio Curiel 34, Paullo, 20067, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100011608 / LOC-100018301


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  2023-10-13 , 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:
    [0000000000300]AMBROXOL HYDROCHLORIDE(en)
    [0000000000348]AMIODARONE HYDROCHLORIDE(en)
    [00000000001062]CHLORDIAZEPOXIDE(en)
    [00000000001120]CLOZAPINE(en)
    [00000000001299]DIAZEPAM(en)
    [00000000001823]FLUNITRAZEPAM(en)
    [00000000005832]LACOSAMIDE(en)
    [00000000007003]LINAGLIPTIN(en)
    [00000000002480]LORMETAZEPAM(en)
    [00000000005496]MARAVIROC(en)
    [00000000001191]PIRFENIDONE(en)
    [00000000003083]SODIUM PICOSULFATE(en)
    [00000000005839]VILDAGLIPTIN(en)
    [00000000004090]ZOLPIDEM TARTRATE(en)
    [00000000004524]EPINEPHRINE BITARTRATE(en)
    [0000000000616]BISACODYL(en)
    [0000000000663]BROTIZOLAM(en)
    [00000000001061]CHLORDIAZEPOXIDE HYDROCHLORIDE(en)
    [00000000002024]GLIPIZIDE(en)
    [00000000005961]TOLVAPTAN(en)
    [00000000007793]BREXPIPRAZOLE(en)
    [00000000004207]CHLORMADINONE ACETATE(en)
    [00000000001620]ETIZOLAM(en)
    [00000000002363]LABETALOL HYDROCHLORIDE(en)
    [00000000002479]LORAZEPAM(en)
    [00000000002688]MIDAZOLAM HYDROCHLORIDE(en)
    [00000000002689]MIDAZOLAM MALEATE(en)
    [00000000002921]OXAZEPAM(en)
    [00000000007565]SALBUTAMOL CRUDE(en)
    [00000000003668]TEMAZEPAM(en)
    [0000000000290]ALPRAZOLAM(en)
    [00000000004196]CYSTEAMINE BITARTRATE(en)
    [00000000001030]CLONAZEPAM(en)
    [00000000001054]DIPOTASSIUM CLORAZEPATE(en)
    [00000000007099]DRONEDARONE HYDROCHLORIDE(en)
    [00000000002848]NOREPINEPHRINE TARTRATE(en)
    [00000000001379]DILTIAZEM HYDROCHLORIDE(en)
    [00000000001544]ERYTHROMYCIN LACTOBIONATE STERILE(en)
    [00000000001872]FLURAZEPAM MONOHYDROCHLORIDE(en)
    [00000000001998]GLIBENCLAMIDE(en)
    [00000000006088]TERPIN HYDRATE(en)
    [0000000000100544]TRELAGLIPTIN SUCCINATE(en)
    [00000000001019]CLOBAZAM(en)
    [00000000007412]ELTROMBOPAG OLAMINE(en)
    [00000000003206]PRAZEPAM(en)
    [00000000003570]SOTALOL HYDROCHLORIDE(en)
    [0000000000425]ARIPIPRAZOLE(en)
    [00000000004209]CHLOROTHIAZIDE(en)
    [00000000001568]ESTAZOLAM(en)
    [00000000007486]IVABRADINE HYDROCHLORIDE(en)
    [00000000005806]RIVAROXABAN(en)
    [00000000004398]SODIUM CROMOGLICATE(en)
    [00000000003865]TRIAZOLAM(en)
    [00000000007653]ALOGLIPTIN BENZOATE(en)
    [0000000000643]BROMAZEPAM(en)
    [0000000000196]EPINEPHRINE(en)
    [00000000001871]FLURAZEPAM DIHYDROCHLORIDE(en)
    [00000000002139]HYDROCHLOROTHIAZIDE(en)
    [0000000000101072]IVABRADINE HYDROCHLORIDE TETRAHYDRATE(en)
    [00000000002533]MEDAZEPAM(en)
    [00000000004316]METHYCLOTHIAZIDE(en)
    [00000000002687]MIDAZOLAM(en)
    [00000000003347]RALOXIFENE HYDROCHLORIDE(en)
    [00000000003393]RIFAXIMIN(en)
    [00000000003436]SALBUTAMOL SULFATE(en)
    [00000000003687]TERBUTALINE SULFATE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:AMBROXOL HYDROCHLORIDE
    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, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:AMIODARONE HYDROCHLORIDE
    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, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

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

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

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

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

    Active Substance:LINAGLIPTIN
    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
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

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

    Active Substance:PIRFENIDONE
    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
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:SODIUM PICOSULFATE
    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,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:VILDAGLIPTIN
    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
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ZOLPIDEM TARTRATE
    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/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:EPINEPHRINE BITARTRATE
    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:BISACODYL
    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, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:CHLORDIAZEPOXIDE HYDROCHLORIDE
    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/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:TOLVAPTAN
    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
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BREXPIPRAZOLE
    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
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:CHLORMADINONE ACETATE
    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)
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:LABETALOL HYDROCHLORIDE
    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/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:MIDAZOLAM HYDROCHLORIDE
    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/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:MIDAZOLAM MALEATE
    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, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:OXAZEPAM
    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:
    pulping
    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, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:SALBUTAMOL CRUDE
    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
    3.5 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:TEMAZEPAM
    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, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:CYSTEAMINE BITARTRATE
    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,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:DIPOTASSIUM CLORAZEPATE
    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/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DRONEDARONE HYDROCHLORIDE
    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, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:NOREPINEPHRINE TARTRATE
    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,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DILTIAZEM HYDROCHLORIDE
    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, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ERYTHROMYCIN LACTOBIONATE STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:FLURAZEPAM MONOHYDROCHLORIDE
    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/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:GLIBENCLAMIDE
    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/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TERPIN HYDRATE
    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)
    3.5.1  Physical processing steps:
    drying, milling/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TRELAGLIPTIN SUCCINATE
    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:CLOBAZAM
    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, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ELTROMBOPAG OLAMINE
    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:PRAZEPAM
    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, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:SOTALOL HYDROCHLORIDE
    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, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ARIPIPRAZOLE
    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/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

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

    Active Substance:IVABRADINE HYDROCHLORIDE
    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/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:RIVAROXABAN
    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:SODIUM CROMOGLICATE
    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/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:ALOGLIPTIN BENZOATE
    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
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

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

    Active Substance:FLURAZEPAM DIHYDROCHLORIDE
    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/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:IVABRADINE HYDROCHLORIDE TETRAHYDRATE
    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/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:MEDAZEPAM
    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/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

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

    Active Substance:RALOXIFENE HYDROCHLORIDE
    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, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:RIFAXIMIN
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    sieving,milling/micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:SALBUTAMOL SULFATE
    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/micronisation, sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TERBUTALINE SULFATE
    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,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    4. Other Activities - Active Substances:
    Importation of: CYSTEAMINE HYDROCHLORIDE CRUDE (confidential), ERYTHROMYCIN (confidential)

    Clarifying remarks (for public users):
    For STERILE ERYTHROMYCIN LACTOBIONATE, sterile filtration and microbiologicaltesting(including sterility testing) are outsourced. Imported active substances marked as confidential undergo further processing within the importing site.According to Italian legislation, sterile active substances are authorized according to art. 40of Dir. 2001/83/EC. On a risk-based approach, the validity of the GMP certificate for thismanufacturing site is not more than 30 months from the latest general GMP inspectionconducted on 2023/10/13, except for AIFA's re-evaluation of the risk profile.

     

     


    		 
    		 
     
         
     
     
    		 
     
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