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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/72/H/2024

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: Bsp Pharmaceuticals S.p.A.

Site address:

Via Appia Km 65,561, Latina Scalo, Latina, 04100, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100011978 / LOC-100022633

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 2022-05-27 , 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.

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:

[00000000007663]SACITUZUMAB GOVITECAN(en)

[0000000000100330]ENFORTUMAB VEDOTIN(en)

[00000000007393]MIRVETUXIMAB SORAVTANSINE(en)

[00000000008152]BRENTUXIMAB VEDOTIN(en)

[00000000008153]LONCASTUXIMAB TESIRINE(en)

[0000000000100947]PATRITUMAB DERUXTECAN (U3-1402)(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:SACITUZUMAB GOVITECAN

3.3 Manufacturing of Active Substance using Biological Processes

3.3.5  Other:
conjugation step monoclonal antibody/toxin

Special Requirements:
7.Other:
Other: Cytotoxic

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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:ENFORTUMAB VEDOTIN

3.3 Manufacturing of Active Substance using Biological Processes

3.3.5  Other:
monoclonal antibody/toxin conjugation step

Special Requirements:
7.Other:
Other: Cytotoxic

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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:MIRVETUXIMAB SORAVTANSINE

3.3 Manufacturing of Active Substance using Biological Processes

3.3.5  Other:
conjugation step monoclonal antibody/toxin

Special Requirements:
7.Other:
Other: Cytotoxic

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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:BRENTUXIMAB VEDOTIN

3.3 Manufacturing of Active Substance using Biological Processes

3.3.5  Other:
conjugation step monoclonal antibody/toxin

Special Requirements:
7.Other:
Other: Cytotoxic

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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:LONCASTUXIMAB TESIRINE

3.3 Manufacturing of Active Substance using Biological Processes

3.3.5  Other:
conjugation step monoclonal antibody/toxin

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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

Active Substance:PATRITUMAB DERUXTECAN (U3-1402)

3.3 Manufacturing of Active Substance using Biological Processes

3.3.5  Other:
conjugation step monoclonal antibody/toxin

Special Requirements:
7.Other:
Other: Cytotoxic

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)

3.6 Quality Control Testing

3.6.4  Biological Testing

3.6.2  Microbiological testing excluding sterility testing

3.6.1  Physical / Chemical testing

4. Other Activities - Active Substances:
Importation of: AGS-22C3 MAB (confidential), BAMLANIVIMAB (confidential), CAC10MAB (confidential), CL2A-SN38 (confidential), DGN549-C (confidential), GUADECITABINE SODIUM (confidential), H2A2 (confidential), MAAA-1162a (confidential), MIRVETUXIMAB, PEMBROLIZUMAB (confidential), RB4V1.2 (confidential), SACITUZUMAB (confidential), SGD-1006 (confidential), XMT-1535 (confidential)

Clarifying remarks (for public users):

Manufactured active substances (AS) marked as confidential are for clinical use only. Imported AS marked as confidential are used for manufacturing AS and medicinal products, also for clinical use, within the importing site and/or a contractor. Importation of AS used for manufacturing medicinal products falls under the responsibility of the QP/QPs listed in the MIA. According to Italian legislation, all the biological active substances listed in this document have undergone an authorization procedure. On a risk-based approach, the validity of the GMP certificate for this manufacturing site is not more than 42 months from the latest general GMP inspection conducted on 2021/11/12, 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.