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National Agency For The Safety Of Medicine And Health Products

CERTIFICATE NUMBER: 23MPP053HVFR02

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
Art. 94(1) of Regulation (EU) 2019/6 as amended

The competent authority of France confirms the following:

The manufacturer: Roquette Freres

Site address:

1 Rue De La Haute Loge, Lestrem, 62136, France

OMS Organisation Id. / OMS Location Id.: ORG-100012502 / LOC-100021241

Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/6 and Art. 111(1) of Directive 2001/83/EC0.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-07-21 , it is considered that it complies with:

The principles of GMP for active substances referred to in Art. 123(6) of Regulation (EU) 2019/6 and 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/EC and Art. 80(5) of Directive 2001/82/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
Veterinary Medicinal Products

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

[FR00640]SORBITOL(en)

[FR17150]GLUCOSE MONOHYDRATE(en)

[FR03011]MANNITOL(en)

[FR]ISOSORBIDE(en)

HYDROXYPROPYLBETADEX(en)

SODIUM GLUCONATE(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:SORBITOL

3.2 Extraction of Active Substance from Natural Sources

3.2.5  Modification of extracted substance Plant

3.2.6  Purification of extracted substance Plant

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Grinding

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:GLUCOSE MONOHYDRATE

3.2 Extraction of Active Substance from Natural Sources

3.2.6  Purification of extracted substance Plant

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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:MANNITOL

3.2 Extraction of Active Substance from Natural Sources

3.2.5  Modification of extracted substance Plant

3.2.6  Purification of extracted substance Plant

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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:ISOSORBIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Purification : Crystallization, Activated carbon

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Flaking

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:HYDROXYPROPYLBETADEX

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Purification

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:SODIUM GLUCONATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
rectification and purification

3.5 General Finishing Steps

3.5.1  Physical processing steps:
atomisation

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

Clarifying remarks (for public users):

SORBITOL: Marketed with the trade name « NEOSORB® PF » (Pyrogen free grade) /// GLUCOSE MONOHYDRATE: Marketed with the trade name « LYCADEX® PF » (Pyrogen free grade) /// MANNITOL: Marketed with the trade name « PEARLITOL® PF » (Pyrogen free grade) /// HYDROXYPROPYLBETADEX : Marketed with the trade names « KLEPTOSE® HPB PARENTERAL GRADE », « KLEPTOSE® HP PARENTERAL GRADE », « KLEPTOSE® HPB-LB PARENTERAL GRADE » with a betadex content nmt 0.5% (Parenteral grades) /// ISOSORBIDE: Marketed with the trade name « ISOSORBIDE C PHARMA » /// SODIUM GLUCONATE : Marketed with the trade name « SODIUM GLUCONATE PHARMA » (Pyrogen free grade) /// Period of validity of the certificate extended to 31st December 2026 /// Signatory: Mrs Virginie Waysbaum, Deputy Director of the Inspection Division --- The ANSM does not issue hard copies of good practices certificates

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.