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Austrian Federal Office For Safety In Health Care

CERTIFICATE NUMBER: 480012-103717782

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 63 of Regulation (EU) 536/2014 as amended
Art. 94(1) of Regulation (EU) 2019/6 as amended
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Austria confirms the following:

The manufacturer: Sandoz GmbH

Site address: Biochemiestrasse 10, Kundl, 6250, Austria

OMS Organisation Id. / OMS Location Id.: ORG-100000546 / LOC-100000450


Other

(Human) API-A123(6)-R2019/6/EU,API-A111(1)-D2001/83/EC,NIP-A40-D2001/83/EC

(Veterinary) NIP-A88-R2019/6/EU

(Investigational product) NIP-A61-R2014/536/EU

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on  2023-11-17 , it is considered that it complies with: 
  • The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (3)
  • The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)  
    		•

    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. 15 of Directive 2001/20/EC, Art. 80(5) of Directive 2001/82/EC and 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
    Human Investigational Medicinal Products
    Veterinary Medicinal Products

    1  MANUFACTURING OPERATIONS
    1.4  Other products or manufacturing activity
       1.4.2  Sterilisation of active substance/ excipients/ finished product
               1.4.2.1  Filtration
       1.4.3  Other: 1.4.3 Andere / Others: Herstellung und Weiterverarbeitung von Zwischenprodukten für Wirkstoffe (z.B. 6-Aminopenicillansäure) / Manufacture and further processing of active substance intermediates (e.g. 6-Aminopenicillanic acid)(en)
    1.6  Quality control testing
       1.6.3  Chemical/Physical

    Manufacture of active substance. Names of substances subject to inspection:
    [900000005273]Cefozopran(en)
    [900000005274]Ceftriaxone(en)
    [900000005275]Ceftiofur Sodium (3-CFT)(en)
    [900000005276]Ceftiofur Hydrochloride (2-CFT)(en)
    [900000005277]Ceftiofur Hydrochloride (CFT.HCl)(en)
    [900000005278]Cefpodoxime Proxetil(en)
    [900000005279]Cefotiam Dihydrochloride(en)
    [900000005280]Ceftazidim Dihydrochloride(en)
    [900000005281]Cefixim (Cefixime)(en)
    [900000005282]Cefdinir (Cefdinir)(en)
    [900000005283]Cefepime(en)
    [900000005306]Cefazolin Sodium sterile(en)
    [900000005307]Ceftriaxon Sodium sterile(en)
    [900000005308]Ceftazidim sterile(en)
    [900000005309]Ceftazidim Pentahydrat for injection/Sodiumcarbonate(en)
    [900000005285]Penicillin V benzathine, 4 % lecithin(en)
    [900000005284]Penicillin V benzathine, 2 % lecithin(en)
    [900000005286]Penicillin V benzathine, 6 % lecithin(en)
    [900000005289]Penicillin V acid pulverized(en)
    [900000005291]Penicillin V potassium(en)
    Romidepsin(en)
    [900000005294]Ampicillin Sodium, sterile(en)
    [900000005293]Amoxicillin Sodium, sterile(en)
    [900000005295]Benzylpenicillin Benzathin, 1,0% lec., pulverized, sterile(en)
    [900000005297]Benzylpenicillin Benzathin, 1,0% lec., 0,2% Tween, pulverized, sterile(en)
    [900000005299]Benzylpenicillin Sodium, buffered, sterile(en)
    [900000005300]Benzylpenicillin Potassium sterile(en)
    [900000005301]Benzylpenicillin Potassium, buffered, sterile(en)
    Benzylpenicillin sodium(en)
    [900000005287]Penicillin V benzathine micronized(en)
    [900000005288]Amoxicillin trihydrat micronized(en)
    [900000005290]Penicillin V acid micronized(en)
    [900000005296]Benzylpenicillin Benzathin, 1,0% lec., 0,2% Tween, microfine, sterile(en)
    [900000005298]Benzylpenicillin Benzathin, micronized, sterile, Benzylpenicillin Sodium sterile(en)
    [900000005302]Benzylpenicillin Procaine, 1% lec., semi-microfine, sterile(en)
    [900000005304]Benzylpenicillin Procaine, 1% lec., microfine, buffered, sterile(en)
    [900000005303]Benzylpenicillin Procaine, 1% lec., microfine, sterile(en)
    [900000005305]Benzylpenicillin Procaine, microfine, sterile(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

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

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

    Active Substance:Ceftiofur Sodium (3-CFT)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Ceftiofur Hydrochloride (2-CFT)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Ceftiofur Hydrochloride (CFT.HCl)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

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

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

    Active Substance:Cefixim (Cefixime)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Cefdinir (Cefdinir)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:Cefazolin Sodium sterile
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Ceftriaxon Sodium sterile
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:Ceftazidim Pentahydrat for injection/Sodiumcarbonate
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Penicillin V benzathine, 4 % lecithin
    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:
    Fällung / precipitation
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.3  Isolation / Purification
    3.3.4  Modification
    3.3.5  Other:
    Salzbildung und enzymatische Spaltung, Synthese / Other: Salt formation and enzymatic cleavage, syn…
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Penicillin V benzathine, 2 % lecithin
    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:
    Fällung / precipitation
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.3  Isolation / Purification
    3.3.4  Modification
    3.3.5  Other:
    Salzbildung und enzymatische Spaltung, Synthese / Other: Salt formation and enzymatic cleavage, syn…
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Penicillin V benzathine, 6 % lecithin
    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:
    Fällung / precipitation
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.3  Isolation / Purification
    3.3.4  Modification
    3.3.5  Other:
    Salzbildung und enzymatische Spaltung, Synthese / Other: Salt formation and enzymatic cleavage, syn…
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Penicillin V acid pulverized
    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:
    Fällung / precipitation
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.3  Isolation / Purification
    3.3.4  Modification
    3.3.5  Other:
    Salzbildung und enzymatische Spaltung, Synthese / Other: Salt formation and enzymatic cleavage, syn…
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Penicillin V potassium
    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:
    Fällung / precipitation
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.3  Isolation / Purification
    3.3.4  Modification
    3.3.5  Other:
    Salzbildung und enzymatische Spaltung, Synthese / Other: Salt formation and enzymatic cleavage, syn…
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

    Active Substance:Ampicillin Sodium, sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Amoxicillin Sodium, sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Benzylpenicillin Benzathin, 1,0% lec., pulverized, sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Benzylpenicillin Benzathin, 1,0% lec., 0,2% Tween, pulverized, sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Benzylpenicillin Sodium, buffered, sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Benzylpenicillin Potassium sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Benzylpenicillin Potassium, buffered, sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Benzylpenicillin sodium
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren /filtration, Trocknen /drying, Mischen / mixing, Sieben/ sieving, Mahlen/ milling, Homog…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Penicillin V benzathine micronized
    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:
    Fällung / Precipitation
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.3  Isolation / Purification
    3.3.4  Modification
    3.3.5  Other:
    Salzbildung und enzymatische Spaltung, Synthese / Other: Salt formation and enzymatic cleavage, syn…
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren / Filtration, Trocknen / Drying, Mischen / Mixing, Sieben / Sieving, Mahlen / Milling, H…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Amoxicillin trihydrat micronized
    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:
    Fällung / Precipitation
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.3  Isolation / Purification
    3.3.4  Modification
    3.3.5  Other:
    Salzbildung und enzymatische Spaltung, Synthese / Other: Salt formation and enzymatic cleavage, syn…
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren / Filtration, Trocknen / Drying, Mischen / Mixing, Sieben / Sieving, Mahlen / Milling, H…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Penicillin V acid micronized
    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:
    Fällung / Precipitation
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.3  Isolation / Purification
    3.3.4  Modification
    3.3.5  Other:
    Salzbildung und enzymatische Spaltung, Synthese / Other: Salt formation and enzymatic cleavage, syn…
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren / Filtration, Trocknen / Drying, Mischen / Mixing, Sieben / Sieving, Mahlen / Milling, H…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Benzylpenicillin Benzathin, 1,0% lec., 0,2% Tween, microfine, sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren / Filtration, Trocknen / Drying, Mischen / Mixing, Sieben / Sieving, Mahlen / Milling, H…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Benzylpenicillin Benzathin, micronized, sterile, Benzylpenicillin Sodium sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren / Filtration, Trocknen / Drying, Mischen / Mixing, Sieben / Sieving, Mahlen / Milling, H…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Benzylpenicillin Procaine, 1% lec., semi-microfine, sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren / Filtration, Trocknen / Drying, Mischen / Mixing, Sieben / Sieving, Mahlen / Milling, H…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Benzylpenicillin Procaine, 1% lec., microfine, buffered, sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren / Filtration, Trocknen / Drying, Mischen / Mixing, Sieben / Sieving, Mahlen / Milling, H…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Benzylpenicillin Procaine, 1% lec., microfine, sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren / Filtration, Trocknen / Drying, Mischen / Mixing, Sieben / Sieving, Mahlen / Milling, H…
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Benzylpenicillin Procaine, microfine, sterile
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    Fällung und Resinbehandlung / Precipitation and resin treatment
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtrieren / Filtration, Trocknen / Drying, Mischen / Mixing, Sieben / Sieving, Mahlen / Milling, H…
    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

    Clarifying remarks (for public users):
    Betreffend Herstellung von Zwischenprodukten für Wirkstoffe: Chemische Modifikation eines Fermentationsproduktes (Semisynthetisch) / Regarding Manufacture of Active substance intermediates: Chemical modification of fermentation products (semisynthetic); Die Herstellung von Amoxicillin Trihydrat umfasst die vollsynthetische und enzymatische; Herstellung / The manufacture of amoxicillin trihydrate includes fully synthetic and enzymatic production; Probebetrieb betreffend folgende Verfahren gültig bis 12/2026: / Regarding the following inspection cases valid until 12/2026: INS-480012-103670929, INS-480012-101699546

     

     


    		 
    		 
     
         
     
     
    		 
     
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