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The Certificate has been withdrawn, withdrawn date is : 2024-06-17

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Health And Youth Care Inspectorate

CERTIFICATE NUMBER: NL/H 22/2045779V2

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Netherlands confirms the following:

The manufacturer: Amgen Singapore Manufacturing Pte Ltd

Site address:

1 Tuas View Drive, Singapore, 637026, Singapore

OMS Organisation Id. / OMS Location Id.: ORG-100030458 / LOC-100047966

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 19(3) of Regulation 726/2004/EC and Art. 8(2) of Regulation (EC) 726/2004.

Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:Art. 100 of the Medicines Act.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2022-12-14 , 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

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

DENOSUMAB(en)

ERENUMAB(en)

ECULIZUMAB(en)

AFLIBERCEPT(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:DENOSUMAB

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.2  Cell Culture:
mammalian cell lines

3.3.3  Isolation / Purification

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:ERENUMAB

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.2  Cell Culture:
mammalian cell lines

3.3.3  Isolation / Purification

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:ECULIZUMAB

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.2  Cell Culture:
mammalian cell lines

3.3.3  Isolation / Purification

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:AFLIBERCEPT

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.2  Cell Culture:
mammalian cell lines

3.3.3  Isolation / Purification

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:
Active Substances (for storage of working cell banks) for denosumab, erenumab, eculizumab, and aflibercept

Any restrictions related to the scope of this certificate:

Building	Room	Line/equipment	QC testing	Products
*ASM1*				*confidential*
*ASM1*				*confidential*
*ASM1*				*confidential*
*ASM1*				*confidential*

Withdrawal comments in English: version contains errors

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.