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Landesamt Fuer Soziales Jugend Und Versorgung

CERTIFICATE NUMBER: DE_RP_01_GMP_2026_0029

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 94(1) of Regulation (EU) 2019/6 as amended

The competent authority of Germany confirms the following:

The manufacturer: Bushu Pharmaceuticals Ltd.

Site address:

1 Takeno, Kawagoe, Saitama, 350-0801, Japan

OMS Organisation Id. / OMS Location Id.: ORG-100011914 / LOC-100022487

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 94(4) of Regulation (EU) 2019/6.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2026-03-18 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)

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. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). 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.

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 80(5) of Directive 2001/82/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.2 Non-sterile products

1.2.1 Non-sterile products (processing operations for the following dosage forms)
1.2.1.13 Tablets

1.5 Packaging

1.5.1 Primary Packaging
1.5.1.13 Tablets

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
*In 6th manufacturing building, 1st & 2nd floor*			*In 1st manufacturing building*	*confidential*

Clarifying remarks (for public users):

Primary packaging for bulk product only.

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.