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Swissmedic Swiss Agency for Therapeutic Products

CERTIFICATE NUMBER: GMPE-CH-1008122

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

Issued under the provisions of the Mutual Recognition Agreement between the European Union and Switzerland .

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

Other

(Human) According to Swiss regulations in force: Therapeutic products act, TPA, SR 812.21 and Medicinal products licensing ordinance, MPLO, RS 812.212.1.

(Veterinary) According to Swiss regulations in force: Therapeutic products act, TPA, SR 812.21 and Medicinal products licensing ordinance, MPLO, RS 812.212.1.

(Investigational product) According to Swiss regulations in force: Therapeutic products act, TPA, SR 812.21 and Medicinal products licensing ordinance, MPLO, RS 812.212.1

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-11-28 , it is considered that it complies with: The Good Manufacturing Practice requirements referred to in the Agreement of Mutual Recognition between the European Union and Switzerland

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. 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.

Part 2

Human Medicinal Products
Human Investigational Medicinal Products
Veterinary Medicinal Products

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

[202]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:
Admilparant, Amezinium metilsulfate, Apixaban, Aprepitant, 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, Deucravacitinib, Enalapril Maleate, Entecavir, Felbamate, Fosinopril sodium, INCB123667, ITI-007 (Aka. Lumateperone),ITI-1284, Mepivacaine Hydrochloride, Methenamine Hippurate, Methylphenidate Hydrochloride, Metolazone, Miltefosine,Niraparib tosylate monohydrate, Oxybutynin, Oxybutynin HCl, Parsaclisib HCl, Phenelzine Sulfate, Pizotifen, Prilocaine, Prilocaine HCl, Raltegravir Potassium, Repotrectinib, Roflumilast,Ropivacaine HCl,Ruxolitinib phosphate, Tetracaine,Tetracaine Hydrochloride,Ticlopidine HCl, Tricaine Methanesulfonate, Trospium Chloride, Valbenazine Tosylate, Xylometazoline HCl, Zanubrutinib.

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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.