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The Certificate has been withdrawn, withdrawn date is : 2024-01-29

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Swissmedic Swiss Agency for Therapeutic Products

CERTIFICATE NUMBER: GMPE-CH-1005314

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of SWITZERLAND confirms the following:

The manufacturer: Novartis Pharma Stein AG

Site address:	Schaffhauserstrasse, Stein, 4332, Switzerland
Additional details on units inspected:	*This GMP-Certificate is valid for the site registered with Swissmedic: Novartis Pharma Stein AG Chemical Operations Schweiz (1000094)*

OMS Organisation Id. / OMS Location Id.: ORG-100001252 / LOC-100000664

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2021-12-10 , 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
Human Investigational Medicinal Products
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.17  Other: Bulk mixtures(en)
   1.2.2  Batch certification

1.5 Packaging

1.5.1 Primary Packaging
1.5.1.17 Other non-sterile medicinal products: Bulk mixtures(en)

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
De-agglomeration, sieving, millling, micronization, co-micronization, blending

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)

4. Other Activities - Active Substances:
CLOZAPINE BASE, FINGOLIMOD HCL, FORMOTEROL FUMARATE, GLYCOPYRRONIUM BROMIDE, NILOTINIB HCL, PASIREOTIDE PAMOATE, PIZOTIFEN HYDROGEN MALEATE, RUXOLITINIB PHOSPHATE, SUCABITRIL, VALSARTAN SODIUM HYDRATE, VILDAGLIPTIN

Withdrawal comments in English: correction

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.