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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/178/H/2023

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: Fresenius Kabi Ipsum S.r.l.

Site address:

Via Enrico Mattei 26, Vicchio, 50039

OMS Organisation Id. / OMS Location Id.: ORG-100015105 / LOC-100052326

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 2022-06-24 , 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:

[00000000002379]LACTULOSE(en)

[00000000005626]LACTULOSE SOLUTION(en)

[00000000005981]LACTULOSE PURIFIED SOLUTION(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:LACTULOSE

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Animal

3.2.5  Modification of extracted substance Animal

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:LACTULOSE SOLUTION

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Animal

3.2.5  Modification of extracted substance Animal

3.2.7  Other:
mixing with excipient

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)

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:LACTULOSE PURIFIED SOLUTION

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Animal

3.2.5  Modification of extracted substance Animal

3.2.7  Other:
purified by cristallization, mixing with excipients

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)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Clarifying remarks (for public users):

According to Italian legislation, all the biological active substances and/or active substances deriving from human and animal tissues, organs, fluids are authorized according to art. 40 of Dir. 2001/83/EC. On a risk-based approach, the validity of the GMP certificate for this manufacturing site is not more than 48months from the latest general GMP inspection conducted on 2022/06/24, 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.