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The Certificate has been invalidated, invalidated date is : 2024-02-23

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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/278/H/2023

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of ITALY confirms the following:

The manufacturer: Biosint S.p.A.

Site address:

Via Del Murillo 16, Sermoneta, 04013, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100015541 / LOC-100024278

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 2022-07-08 , it is considered that it complies with:

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

Part 2

Human Medicinal Products

Manufacture of active substance. Names of substances subject to inspection:

[00000000005742]COCARBOXYLASE TETRAHYDRATE(en)

[0000000000799]LEVOCARNITINE PROPIONATE HYDROCHLORIDE(en)

[00000000005063]ACETYL L-CARNITINE HYDROCHLORIDE(en)

[0000000000803]L-CARNITINE HYDROCHLORIDE(en)

[00000000005647]ACETYL L - CARNITINE(en)

[00000000002401]LEVOCARNITINE(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:COCARBOXYLASE TETRAHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.1  Manufacture of active substance intermediates

3.1.3  Salt formation / Purification steps:
purification,crystallisation

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)

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.1  Physical processing steps:
drying,sieving

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:LEVOCARNITINE PROPIONATE HYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
crystallisation

3.1.2  Manufacture of crude active substance

3.1.1  Manufacture of active substance intermediates

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)

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.1  Physical processing steps:
drying,sieving

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:ACETYL L-CARNITINE HYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
crystallisation

3.1.2  Manufacture of crude active substance

3.1.1  Manufacture of active substance intermediates

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)

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.1  Physical processing steps:
drying,sieving

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:L-CARNITINE HYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.1  Manufacture of active substance intermediates

3.1.3  Salt formation / Purification steps:
salt formation,crystallisation

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)

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.1  Physical processing steps:
drying,sieving

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:ACETYL L - CARNITINE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.1  Manufacture of active substance intermediates

3.1.3  Salt formation / Purification steps:
purification,crystallisation

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)

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.1  Physical processing steps:
drying,sieving

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:LEVOCARNITINE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.1  Manufacture of active substance intermediates

3.1.3  Salt formation / Purification steps:
purification,crystallisation

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)

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.1  Physical processing steps:
drying,sieving

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Clarifying remarks (for public users):

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 2022/07/08, 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.