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Spanish Agency Of Medicines And Medical Devices

CERTIFICATE NUMBER: ES/099HV/25

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

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended
Art. 94(1) of Regulation (EU) 2019/6 as amended

The competent authority of Spain confirms the following:

The manufacturer: Hebei Shengxue Dacheng Pharmaceutical Co. Ltd.

Site address:

No. 50 Shengxue Road, Luanchengxian, Shijiazhuang, Hebei, 051430, China

OMS Organisation Id. / OMS Location Id.: ORG-100016575 / LOC-100025368

DUNS Number: 54-486-7229

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 and Art. 111(4) of Directive 2001/83/EC.

Other

(Human) Real Decreto 824/2010, de 25 de junio, artículo 108.2c, Real Decreto Legislativo 1/2015, de 24 de julio, Directiva (UE) 2017/1572, Directiva 91/412/CE

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-06-15 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)

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. 111(5) of Directive 2001/83/EC and 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

Human Medicinal Products
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.1 Aseptically prepared (processing operations for the following dosage forms)
1.1.1.6 Other: [HV] Fabricación de sustancias activas estériles e intermedios estériles/Manufacture of sterile active substances and sterile intermediates(en)

1.6 Quality control testing

1.6.1 Microbiological: sterility
1.6.3 Chemical/Physical

Clarifying remarks (for public users):

[F/HV]No. 50 Shengxue Road: Streptomycin Sulphate, sterile active substance and sterile intermediate, using biological processes: Fermentation. Preparation and storage of Master Cell Bank only.No. 57 Zhangju Road: Manufacture of Streptomycin sulphate, sterile active substance and sterile intermediate, using biological processes (Working Cell Bank preparation, fermentation, isolation, purification, filtration, spray drying and packaging).Certificate issued based on a distant assesment. This certificate is valid up to 15/06/2027.;

Withdrawal comments in English: The inspection carried out by AEMPS at HEBEI SHENGXUE DACHENG PHARMACEUTICAL CO. LTD., from 22-26 May 2023 and 5-7 and 14-15 June 2023 was conducted remotely due to travel restrictions, and the certificate could not be issued until the company submitted multiple CAPAs and commitments. Given the deficiencies observed in the inspection carried out on-site by EDQM and Swissmedic in December 2025 (Statement of non-compliances with GMP report number CH25-0004), AEMPS conclude that the deficiencies detected in the inspection of 2023 have not been resolved and the CAPA and commitments submitted by the company have not been implemented , therefore, this GMP certificate is revoked.

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.