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National Agency For The Safety Of Medicine And Health Products

CERTIFICATE NUMBER: 23MPP054HFR01

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 France confirms the following:

The manufacturer: Oril Industrie

Site address:

13 Rue Auguste Desgenetais, Bolbec, 76210, France

OMS Organisation Id. / OMS Location Id.: ORG-100012082 / LOC-100022735

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 2023-09-15 , 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:

ATORVASTATIN CALCIUM TRIHYDRATE(en)

RILMENIDINE DIHYDROGEN PHOSPHATE(en)

AGOMELATINE(en)

FOTEMUSTINE(en)

IVABRADINE(en)

GLICLAZIDE(en)

TRIMETAZIDINE DIHYDROCHLORIDE(en)

INDAPAMIDE(en)

PIRIBEDIL(en)

PERINDOPRIL ARGININE(en)

PERINDOPRIL TERT-BUTYLAMINE(en)

TIANEPTINE SODIUM(en)

FONDAPARINUX SODIUM(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:ATORVASTATIN CALCIUM TRIHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
precipitation / crystallization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, milling

Active Substance:RILMENIDINE DIHYDROGEN PHOSPHATE

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:
precipitation / crystallization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, milling

Active Substance:AGOMELATINE

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:
precipitation / crystallization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, milling

Active Substance:FOTEMUSTINE

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:
precipitation / crystallization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, milling

Active Substance:IVABRADINE

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:
precipitation / crystallization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, milling

Active Substance:GLICLAZIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

Active Substance:TRIMETAZIDINE DIHYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

Active Substance:INDAPAMIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Crystallization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, grinding

Active Substance:PIRIBEDIL

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
precipitation / crystallization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, grinding

Active Substance:PERINDOPRIL ARGININE

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:
precipitation / crystallization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, grinding

Active Substance:PERINDOPRIL TERT-BUTYLAMINE

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:
precipitation / crystallization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, grinding

Active Substance:TIANEPTINE SODIUM

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:
cristallization, sodium salt formation

Active Substance:FONDAPARINUX SODIUM

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

Clarifying remarks (for public users):

Packaging, labelling and quality control activities are subcontracted to Oril Baclair site /// Fondaparinux sodium : limited to the manufacture of the intermediate crude Fondaparinux sodium /// Gliclazide : limited to the manufacture of the intermediate Purified 852 aminaza /// Trimetazidine dihydrochloride : limited to the manufacture of the intermediate Trimetazidine base /// Tianeptine sodium : lyophilization step is subcontracted /// Signatory : Mrs Linda Gallais, head of starting materials inspection department --- 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.