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Austrian Agency For Health And Food Safety

CERTIFICATE NUMBER: 483963-104510196

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

The competent authority of Austria confirms the following:

The manufacturer: Shandong Anxin Pharmaceutical Co. Ltd.

Site address:

No 849 Dongjia Town, Licheng, Jinan, Shandong, 250105, China

OMS Organisation Id. / OMS Location Id.: ORG-100012114 / LOC-100018602

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 111(4) of Directive 2001/83/EC transposed in the following national legislation:§ 63 Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

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:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2025-11-14 , 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 of GMP for active substances referred to in Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC transposed in the following national legislation:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

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/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

1 MANUFACTURING OPERATIONS

1.1 Sterile products

1.1.1 Aseptically prepared (processing operations for the following dosage forms)
1.1.1.6 Other: Intermediate Drug Product Piperacillin Sodium and Tazobactam Sodium 8:1, Finished Drug Product Piperacillin Sodium and Tazobactam Sodium for Injection, 4.5g(en)

1.5 Packaging

1.5.2 Secondary packaging

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

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

PIPERACILLIN SODIUM(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:PIPERACILLIN SODIUM

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Salification

3.4 Manufacture of sterile Active Substance

3.4.1  Aseptically prepared

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Sterile filtration, Lyophilisation, Granulation, Filling

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

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.3  Microbiological testing including sterility testing

3.6.4  Biological Testing

Clarifying remarks (for public users):

The inspection covered: aseptic manufacturing of sterile Intermediate Drug Product “Piperacillin Sodium and Tazobactam Sodium 8:1” in workshops 2000 (line 1), 2300 (line 1), 2600 (line 1&2) and sterile API Piperacillin Sodium in workshops 2300 (line 1) aseptic manufacturing of Finished Drug Product “Piperacillin Sodium and Tazobactam; Sodium for Injection, 4.5g” in workshops 2500 (line 2), 2800 (line 1&2) Registration Address: No. 10678 Wenliang Road, Dongjia Town, Licheng District, Jinan, China Manufacturing Address: No. 849 Dongjia Town, Licheng District, Jinan, China Both addresses are access points to the inspected manufacturing site

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.