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Ministry Of Health Labour And Welfare

CERTIFICATE NUMBER: 24MHLW0833

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

Issued under the provisions of the Mutual Recognition Agreement between the European Union and Japan .
Issued following an inspection in accordance with

The competent authority of Japan confirms the following:

The manufacturer: Cmic Cmo Co. Ltd.

Site address:

154 13, Dai 2 Chiwari Obuke, Hachimantai, 028-7111, Japan

OMS Organisation Id. / OMS Location Id.: ORG-100025060 / LOC-100061704

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-10-04 , 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 Japan

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

1 MANUFACTURING OPERATIONS

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.1  Capsules, hard shell
   1.2.2  Batch certification

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

Any restrictions related to the scope of this certificate:

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

Clarifying remarks (for public users):

[License Number:03AZ200009]MHLW certifies the GMP Compliance of all manufacturing operations in the above manufacturing site for the products specified in the certificate. Due to different terminology of manufacturing operations in Japan and the EU, the items listed in Part 2 have been selected by the manufacturer and the MHLW bears no responsibility for this information.

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.