Eudra GMP - Public Layout

MIA | GMP | API REG | WDA | GDP | Sites

Help

Tue 10 Nov 2026 14:06:54 BST

GMP Compliance Menu

GMP Certificates

Non-Compliance Report

Print Preview

Print Preview (Short version)

Back To Search

Swissmedic Swiss Agency for Therapeutic Products

CERTIFICATE NUMBER: GMPE-CH-1006195

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: Incyte Biosciences Technical Operations S.a.r.l.

Site address:

Avenue Des Sciences 12, Yverdon Les Bains, 1400, Switzerland

OMS Organisation Id. / OMS Location Id.: ORG-100041044 / LOC-100067574

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 2024-07-26 , 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:

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

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

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

3.3 Manufacturing of Active Substance using Biological Processes

3.3.2  Cell Culture:
mammalian cell culture (Chinese Hamster Ovarian Cells (CHO))

3.3.3  Isolation / Purification

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Freezing

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

4. Other Activities - Active Substances:
Tafasitamab-cxix

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.