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The Spanish Agency Of Medicines And Medical Devices

CERTIFICATE NUMBER: ES/076/24

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

Part 1

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

The competent authority of Spain confirms the following:

The manufacturer: Ercros S.A.

Site address: Paseo Del Deleite S\n, Aranjuez, 28300, Spain

OMS Organisation Id. / OMS Location Id.: ORG-100016091 / LOC-100024873


Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/6 and Art. 111(1) of Directive 2001/83/EC0.

Other

(Human) artículo 108, Real Decreto Legislativo 1/2015, de 24 de julio, artículo 64, Real Decreto Legislativo 1/2015, de 24 de julio, Real Decreto 824/2010, de 25 de junio, artículo 47 de la Directiva 2001/83/CE

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on  2024-03-15 , it is considered that it complies with:

  • The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)
  • The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)  
  • The principles of GMP for active substances referred to in Art. 123(6) of Regulation (EU) 2019/6 and 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. 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
    Veterinary Medicinal Products

    Manufacture of active substance. Names of substances subject to inspection:
    [7177]AMLODIPINE BESILATE(en)
    [7796]AZITHROMYCIN DIHYDRATE(en)
    [7214]CLARITHROMYCIN(en)
    [1950]erythromycin(en)
    [1953]ERYTHROMYCIN STEARATE(en)
    [1951]ERYTHROMYCIN ESTOLATE(en)
    [1952]ERYTHROMYCIN ETHYLSUCCINATE(en)
    [1956]ERYTHROMYCIN PROPIONATE(en)
    [6834]famotidine(en)
    [1668]PHOSPHOCREATINE(en)
    [2387]FOSFOMYCIN CALCIUM(en)
    [2388]FOSFOMYCIN DISODIUM(en)
    [6655]FOSFOMYCIN TROMETAMOL(en)
    [676]DIETHANOLAMINE FUSIDATE(en)
    [2438]FUSIDATE SODIUM(en)
    [2437]FUSIDIC ACID(en)
    [2490]GENTAMICIN SULFATE(en)
    [1200]TERBINAFINE HYDROCHLORIDE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

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

    Active Substance:AZITHROMYCIN DIHYDRATE
    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
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Milling and sieving
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:CLARITHROMYCIN
    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
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:erythromycin
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.4  Other:
    Recrystallization of the anhydrous API to obtain the dihydrate grade
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.3  Isolation / Purification
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving; Milling; Micronization (not every batch)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:ERYTHROMYCIN STEARATE
    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:
    Stearic salt of Erythromycin
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving; Milling
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:ERYTHROMYCIN ESTOLATE
    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
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving; Milling; Compaction (not every batch)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:ERYTHROMYCIN ETHYLSUCCINATE
    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
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving; Milling; Micronization (not every batch); Compaction (not every batch)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:ERYTHROMYCIN PROPIONATE
    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
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving; Milling
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:famotidine
    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
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving; Micronization (not every batch)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:PHOSPHOCREATINE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.4  Other:
    Sterilization of the non-sterile product
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Milling and sieving
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.3  Microbiological testing including sterility testing

    Active Substance:FOSFOMYCIN CALCIUM
    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:
    Calcium salt of Fosfomycin
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving; Compaction (not every batch)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:FOSFOMYCIN DISODIUM
    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:
    Disodium salt of Fosfomycin
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving NE + Milling-Sieving E
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.3  Microbiological testing including sterility testing

    Active Substance:FOSFOMYCIN TROMETAMOL
    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:
    Trometamol Salt of Fosfomycin
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving; Compaction (not every batch)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:DIETHANOLAMINE FUSIDATE
    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:
    Diethanolaminic salt of Fusidic Acid
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving; Milling
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:FUSIDATE SODIUM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Sodium salt of Fusidic Acid
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving; Milling; Micronization (not every batch); Compaction (not every batch)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.3  Microbiological testing including sterility testing

    Active Substance:FUSIDIC ACID
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.3  Isolation / Purification
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving; Milling; Micronization (not every batch); Compaction (not every batch)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.3  Microbiological testing including sterility testing

    Active Substance:GENTAMICIN SULFATE
    3.3 Manufacturing of Active Substance using Biological Processes
     
    3.3.1  Fermentation
    3.3.3  Isolation / Purification
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Milling
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing

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

     

     


    		 
    		 
     
         
     
     
    		 
     
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