EudraGMP Homepage      
 
 
MIA | GMP | API REG | WDA | GDP | Sites Help
Tue 10 Nov 2026 14:48:37 BST
GMP Compliance Menu 
Search
GMP Certificates
Non-Compliance Report


Print Preview
                   
Print Preview (Short version)
                  
Back To Search

 

Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/91/H/2025

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

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Italy confirms the following:

The manufacturer: Biofer S.p.A.

Site address: Via Canina 2, Medolla, 41036

OMS Organisation Id. / OMS Location Id.: ORG-100007069 / LOC-100011468


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

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on  2025-02-07 , it is considered that it complies with:

  • The principles of GMP for active substances referred to in Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC.
    		•

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

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

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

    Part 2

    Human Medicinal Products

    Manufacture of active substance. Names of substances subject to inspection:
    [0000000005834]FERRIC SODIUM GLUCONATE(en)
    [0000000001503]HEPARIN CALCIUM(en)
    [0000000002158]HYDROCORTISONE SODIUM SUCCINATE BUFFERED STERILE(en)
    [0000000005833]FERRIC HYDROXIDE POLYMALTOSE COMPLEX(en)
    [0000000001502]HEPARAN SULFATE(en)
    [0000000004796]ACTIVE SUBSTANCES (STERILE AND/OR BIOLOGICAL AND/OR FROM HUMAN AND ANIMAL TISSUES, ORGANS, FLUIDS)(en)
    [0000000001751]FERRIC ACETYL TRASFERRIN(en)
    [0000000001752]IRON PROTEIN ACETYL ASPARTYLATE(en)
    [0000000002639]METHYLPREDNISOLONE SODIUM SUCCINATE BUFFERED STERILE(en)
    [0000000005836]IRON SUCROSE(en)
    [0000000002635]METHYLPREDNISOLONE HYDROGEN SUCCINATE(en)
    [0000000005835]IRON DEXTRAN(en)
    [0000000007986]CALCIUM FOLINATE HYDRATE(en)
    [0000000005899]THIOPENTAL SODIUM AND SODIUM CARBONATE STERILE(en)
    [0000000002593]MESOGLYCAN(en)
    [0000000002151]HYDROCORTISONE HYDROGEN SUCCINATE(en)
    [0000000001504]HEPARIN SODIUM(en)
    [0000000003632]SULODEXIDE(en)
    [0000000005837]SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:FERRIC SODIUM GLUCONATE
    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:
    Ultrafiltration
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Spray drying
    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:HEPARIN CALCIUM
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Animal 
    3.2.7  Other:
    salification
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Lyophilization, granulation
    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:HYDROCORTISONE SODIUM SUCCINATE BUFFERED STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.3  Salt formation / Purification steps:
    precipitation
    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:FERRIC HYDROXIDE POLYMALTOSE COMPLEX
    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:
    Ultrafiltration
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Spray drying
    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:HEPARAN SULFATE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.5  Modification of extracted substance Animal 
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Lyophilization
    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:ACTIVE SUBSTANCES (STERILE AND/OR BIOLOGICAL AND/OR FROM HUMAN AND ANIMAL TISSUES, ORGANS, FLUIDS)
    3.5 General Finishing Steps
     
    3.5.4  Other:
    Storage

    Active Substance:FERRIC ACETYL TRASFERRIN
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.5  Modification of extracted substance Animal 
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Spray drying
    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:IRON PROTEIN ACETYL ASPARTYLATE
    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:
    Filtration
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, granulation
    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:METHYLPREDNISOLONE SODIUM SUCCINATE BUFFERED STERILE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.3  Salt formation / Purification steps:
    precipitation
    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:IRON SUCROSE
    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:
    Ultrafiltration
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Lyophilization, granulation
    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:METHYLPREDNISOLONE HYDROGEN SUCCINATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.3  Salt formation / Purification steps:
    precipitation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, granulazione
    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:IRON DEXTRAN
    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:
    Ultrafiltration
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Spray drying
    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:CALCIUM FOLINATE HYDRATE
    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:
    Crystallization, Salt formation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, granulation
    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:THIOPENTAL SODIUM AND SODIUM CARBONATE STERILE
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.4  Other:
    Batch certification
    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:MESOGLYCAN
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Granulation, Lyophilization
    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:HYDROCORTISONE HYDROGEN SUCCINATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.3  Salt formation / Purification steps:
    precipitation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, granulation
    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:HEPARIN SODIUM
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Lyophilization, granulation
    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:SULODEXIDE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.6  Purification of extracted substance Animal 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Spray drying
    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:SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
    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:
    Ultrafiltration
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Lyophilization, granulation
    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

    4. Other Activities - Active Substances:
    Importation of: FOLIC ACID (confidential), HEPARINOID CRUDE (confidential), HEPARIN SODIUM CRUDE (confidential), METHYLPREDNISOLONE (confidential), THIOPENTAL (confidential), HYDROCORTISONE (confidential), CALCIUM FOLINATE CRUDE (confidential)

    Clarifying remarks (for public users):
    Imported active substances (AS) marked as confidential undergo further processing within the importing site and/or are released to other AS manufacturing sites for processing.Thiopental imported is given to other AS manufacturing company for sterile active substance manufacturing. Raw Heparinoid imported by Smithfield Bioscience INC. USA, is given to other AS manufacturing companies for processing. Hydrocortisone sodium succinate sterile buffered, Methylprednisolone sodium succinate sterile buffered: via sterile filtration (outsourced). Ferro protein acetyl aspartylate lyophilized also. On a risk-based approach, the validity of the GMP certificate for this manufacturing site is not more than 36 months from the latest general GMP inspection conducted on 2025/02/07, except for AIFA's re-evaluation of the risk profile.

     

     


    		 
    		 
     
         
     
     
    		 
     
    The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

    Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.
    [EMA © 2014. EudraGMDP 6.5.4.8 build 2026/01/16 09:45]