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Generalitat De Catalunya

CERTIFICATE NUMBER: NCF-II/2418/001/CAT

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: Bcn Peptides S.A.

Site address: Poligono Industrial Els Vinyets Els Fogars Sector II, Sant Quinti De Mediona, 08777

OMS Organisation Id. / OMS Location Id.: ORG-100007107 / LOC-100010600


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  2023-10-02 , 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:
    [8118]LECIRELIN ACETATE(en)
    [12630]ALARELIN(en)
    [11299]ATOSIBAN ACETATE(en)
    [4751]BUSERELIN ACETATE(en)
    [11412]SALMON CALCITONIN ACETATE(en)
    [9544]carbetocin(en)
    [11425]CARPERITIDE ACETATE(en)
    [12742]CETRORELIX ACETATE(en)
    [11424]CORTICOTROPIN ACETATE(en)
    [9816]DESLORELIN ACETATE(en)
    [6822]DESMOPRESSIN ACETATE(en)
    [7196]elcatonin(en)
    [4704]ELEDOISIN TRIFLUOROACETATE(en)
    [9183]FERTIRELIN ACETATE(en)
    [10937]GANIRELIX ACETATE(en)
    [11429]GLUCAGON ACETATE(en)
    [8678]GONADORELIN ACETATE(en)
    [11991]SALMON GONADORELIN(en)
    [11306]GONADORELIN DIACETATE(en)
    [6610]GOSERELIN ACETATE(en)
    [10230]ICATIBANT ACETATE(en)
    [1403]LANREOTIDE ACETATE(en)
    [4717]LEUPRORELIN ACETATE(en)
    [11418]LYPRESSIN ACETATE(en)
    [11423]NESIRITIDE ACETATE(en)
    [9636]OCTREOTIDE ACETATE(en)
    [11422]PENTAGASTRIN ACETATE(en)
    [11415]VASOACTIVE INTESTINAL PEPTIDE ACETATE(en)
    [11419]PROTIRELIN ACETATE(en)
    [6775]SOMATOSTATIN ACETATE MONOHYDRATE(en)
    [626]TERIPARATIDE ACETATE(en)
    [10555]TERLIPRESSIN ACETATE(en)
    [11113]TETRACOSACTIDE ACETATE(en)
    [11421]THYMOSIN ALPHA 1 ACETATE(en)
    [11428]THYMOSIN BETA 4 ACETATE(en)
    [567]TRIPTORELIN ACETATE(en)
    [11414]VASOPRESSIN ACETATE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:LECIRELIN ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Ion exchange. Purification by preparative HPLC
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophillisation
    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
    3.6.4  Biological Testing

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

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

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

    Active Substance:SALMON CALCITONIN ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Ion exchange. Purification by preparative HPLC
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophilisation
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.3  Microbiological testing including sterility testing
    3.6.4  Biological Testing

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

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

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

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

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

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

    Active Substance:elcatonin
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Ion exchange. Purification by preparative HPLC
    3.4 Manufacture of sterile Active Substance
     
    3.4.1  Aseptically prepared
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophillisation
    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
    3.6.3  Microbiological testing including sterility testing
    3.6.4  Biological Testing

    Active Substance:ELEDOISIN TRIFLUOROACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Trifluoroacetat acqusition counterion at the stage of chemical syntesis, purification
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophillisation
    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
    3.6.4  Biological Testing

    Active Substance:FERTIRELIN ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Ion exchange. Purification by preparative HPLC
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophillisation
    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
    3.6.4  Biological Testing

    Active Substance:GANIRELIX ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Ion exchange. Purification by preparative HPLC
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophillisation
    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
    3.6.4  Biological Testing

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

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

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

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

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

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

    Active Substance:LANREOTIDE ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Ion exchange. Purification by preparative HPLC
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophillisation
    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
    3.6.4  Biological Testing

    Active Substance:LEUPRORELIN ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Ion exrchange. Purification by preparative HPLC
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophillisation
    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
    3.6.4  Biological Testing

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

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

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

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

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

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

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

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

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

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

    Active Substance:THYMOSIN ALPHA 1 ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Ion exchange. Purification by preparative HPLC
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophilisation
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

    Active Substance:THYMOSIN BETA 4 ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Ion exchange. Purification by preparative HPLC
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    lyophilisation
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    3.6.2  Microbiological testing excluding sterility testing
    3.6.4  Biological Testing

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

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

     

     


    		 
    		 
     
         
     
     
    		 
     
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