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Health Products Regulatory Authority

CERTIFICATE NUMBER: 35879/ASR11450

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 Ireland confirms the following:

The manufacturer: Sterling Pharma Ringaskiddy Limited

Site address: Ringaskiddy, Cork, P43 FR63, Ireland

OMS Organisation Id. / OMS Location Id.: ORG-100012524 / LOC-100021664


Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539/2007), as amended..

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on  2025-06-27 , it is considered that it complies with:

  • The principles of GMP for active substances referred to in Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC transposed in the following national legislation:Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539/2007), as amended..
    		•

    This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

     The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

    __________________________________________________________________________________________________________________________
    (1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/ECis also applicable to importers.
    (2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
    (3) These requirements fulfil the GMP recommendations of WHO.

    Part 2

    Human Medicinal Products

    Manufacture of active substance. Names of substances subject to inspection:
    [11720]CALCITONIN(en)
    [11721]CICLOSPORIN(en)
    [11722]FLUVASTATIN SODIUM(en)
    [14998]IMATINIB MESILATE(en)
    [11724]KETOTIFEN HYDROGEN FUMARATE(en)
    [11725]OCTREOTIDE ACETATE(en)
    [11726]PASIREOTIDE DI-ASPARTATE(en)
    [11729]TERABINAFINE BASE(en)
    [11730]VALSARTAN(en)
    [15000]NILOTINIB HYDROCHLORIDE(en)
    [15001]GLYCOPYRRONIUM BROMIDE(en)
    [11732]CLOZAPINE BASE(en)
    [11734]INDACATEROL MALEATE (INTERMEDIATE)(en)
    [11737]PASIREOTIDE PAMOATE(en)
    [11739]TERBINAFINE HYDROCHLORIDE(en)
    RIVASTIGMINE HYDROGEN TARTRATE(en)
    [18878]RIVASTIGMINE BASE(en)
    RUXOLITINIB PHOSPHATE(en)
    DABRAFENIB MESYLATE(en)
    INDACATEROL ACETATE(en)
    CAPMATINIB HYDROCHLORIDE(en)
    SACUBITRIL VALSARTAN SODIUM HYDRATE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Active Substance:RIVASTIGMINE HYDROGEN TARTRATE
    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:
    Salt formation, Crytsallization, Isolation, Washing , Drying.
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying,Milling/Micronisation, 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:RIVASTIGMINE BASE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    .
    3.5 General Finishing Steps
     
    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:RUXOLITINIB PHOSPHATE
    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:
    Salt formation, Crystallization, Isolation, Washing , Drying.
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Milling, Sieving
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

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

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

    Active Substance:SACUBITRIL VALSARTAN SODIUM HYDRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.3  Salt formation / Purification steps:
    formation of sodium salt & crystallisation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, milling/micronisation, 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

     

     

    Withdrawal comments in English: Withdrawn to account for a variation to remove the manufacture of some active substances.

    		 
    		 
     
         
     
     
    		 
     
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