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The Certificate has been withdrawn, withdrawn date is : 2026-09-16

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Regierung Von Oberbayern

CERTIFICATE NUMBER: DE_BY_04_GMP_2026_0090

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 Germany confirms the following:

The manufacturer: Anqiu Lu'An Pharmaceutical Co. Ltd.

Site address:

No. 35 Weixu North Road, Anqiu, Weifang, Shandong, 262100, China

OMS Organisation Id. / OMS Location Id.: ORG-100020492 / LOC-100029247

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:Sect. 72a para 1 sent. 1 No. 2 in conjunction with sent. 3 No. 1 German Medicinal Product Act (import certificate).

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:Sect. 64 para 1 and 3 German Medicinal Product Act.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2026-06-10 , 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:Sect. 64 para 1 and 3 German Medicinal Product Act.

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

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.13  Tablets
           1.2.1.17  Other: Granules - see under any restrictions or clarifying remerks related to the scope of this certificate(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.13  Tablets
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

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

[00026047-00001]Paracetamol API(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Paracetamol API

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Acetylation / Decoloration / Filtration / Crystallization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying / Blending / Milling

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

3.6.2  Microbiological testing excluding sterility testing

Clarifying remarks (for public users):

To API Production: Paracetamol API Workshop No. 1 (Building No. 7) and Workshop No. 5 (Building No. 51) Production at the inspected manufacturing site is initiated with the intermediate 4-Aminophenol (this EU-GMP certificate does not cover the manufacture of the intermediate 4-Aminophenol) To Point 1.2.1.13 tablets (from granules as clarified under point 1.2.1.17) FDF Workshop No. 2 (Building No. 14; Production line on the 3rd floor and 4th floor) (including coated tablets) To Point 1.2.1.17 Granules Name (Product): Paracetamol DC90 (direct compression) Paracetamol DC96 (direct compression) Paracetamol DC85 (direct compression) Paracetamol DC83 (direct compression) Paracetamol DC77 (direct compression) Paracetamol DC Workshop No. 1 (DC WS-1; Building No. 11) Name (Product): Paracetamol DC90 (direct compression) Paracetamol DC96 (direct compression) Paracetamol DC86 (direct compression) Paracetamol DC Workshop No. 2 (DC WS-2; Building No. 58) Name (Product) (text missing)

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_BY_04_GMP_2026_0139

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_BY_04_GMP_2026_0139

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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.