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Non-Compliance Report

The Certificate has been withdrawn, withdrawn date is : 2023-09-15

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Swissmedic Swiss Agency for Therapeutic Products

CERTIFICATE NUMBER: GMPEHV-CH-1004762

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of SWITZERLAND confirms the following:

The manufacturer: Siegfried Evionnaz S.A.

Site address:

Route Du Simplon 1/36, Evionnaz, 1902, Switzerland

OMS Organisation Id. / OMS Location Id.: ORG-100011796 / LOC-100019013

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-10-07 , 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
Veterinary Medicinal Products

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

[1]SWISSMEDIC LIST OF APIS, SEE 4 ACTIVE SUBSTANCES(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:SWISSMEDIC LIST OF APIS, SEE 4 ACTIVE SUBSTANCES

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:
recrystallization, distillation, delaying

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, sieving, milling, micronisation

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

4. Other Activities - Active Substances:
Amezinium metilsulfate, Apixaban, Benoxinate Hydrochloride (Oxybuprocaine Hydrochloride), Benzonatate, Bethanechol Chloride, Biperiden HCl, Biperiden base, Bupivacaine, Bupivacaine Hydrochloride, Butamirate citrate, Cannabidiol, Chloroprocaine Hydrochloride, Choline Salicylate 80%, Cyclizine Hydrochloride, Dasatinib, Enalapril Maleate, Entecavir, Felbamate, Fosinopril sodium, lTI-007 (Aka. Lumateperone), lTI-1284, Mefloquine Hydrochloride, Mepivacaine Hydrochloride, Methenamine Hippurate, Methylphenidate Hydrochloride, Metolazone, Miltefosine, Niraparib tosylate monohydrate, Oxybutynin, Oxybutynin Hydrochloride, Parsaclisib hydrochloride, Phenelzine Sulfate, Prilocaine, Prilocaine Hydrochloride, Roflumilast, Ropivacaine Hydrochloride, Tetracaine, Tetracaine Hydrochloride, Ticlopidine Hydrochloride, Tricaine Methanesulfonate, Trospium Chloride, Xylometazoline Hydrochloride, Ruxolitinib phosphate

Withdrawal comments in English: correction

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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.