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Non-Compliance Report

The Certificate has been withdrawn, withdrawn date is : 2026-01-20

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Bezirksregierung Muenster

CERTIFICATE NUMBER: DE_NW_05_GMP_2025_0037

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

Part 1

Issued following an inspection in accordance with
Art. 15 of Directive 2001/20/EC as amended
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Germany confirms the following:

The manufacturer: Rottendorf Pharma GmbH

Site address:

Ostenfelder Strasse 51-61, Ennigerloh, North Rhine-Westphalia, 59320, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100011762 / LOC-100020726

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_NW_05_MIA_2025_0016 in accordance with Art. 13 of Directive 2001/20/EC and Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Sect. 13 para 1 German Medicinal Product Act (manufacture) and § 72 German Medicinal Product Act (import) and Sect. 13 para 1 German Medicinal Product Act (manufacture) and § 72 German Medicinal Product Act (import).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-03-14 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (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. 15 of Directive 2001/20/EC and 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
Human Investigational 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
           1.2.1.2  Capsules, soft shell
           1.2.1.8  Other solid dosage forms
           1.2.1.13  Tablets
   1.2.2  Batch certification

1.4 Other products or manufacturing activity

   1.4.1  Manufacture of
           1.4.1.1  Herbal products
           1.4.1.2  Homoeopathic products
           1.4.1.3  Other: Crushing of extracts for the production of active ingredients(en)

1.5 Packaging

1.5.1 Primary Packaging
1.5.1.8 Other solid dosage forms

1.6 Quality control testing

1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.2 Batch certification of imported medicinal products

2.2.2 Non-sterile products

2.3 Other importation activities

2.3.4 Other: active substance "Tacrolimus" manufacturer: Biocon Ltd. 20th KM Hosur Road, Electronics City 560 100 Bengaluru and manufacturer: Chunghwa Chemical Sythesis & Biotech CO LTD 1 Tung-Hsing Street Chu-Lin Dist. 23850 New Taipei City(en)

Clarifying remarks (for public users):

Regarding point 1.2.1.8: Powder, pellets, granules Regarding point 1.2.1.13: As well effervescent tablets, coated tablets and vaginal tablets Regarding point 1.4.1.3: Only active ingredients for Sinupret extract dragees Regarding point 1.6.3: Sterile and non-sterile products Regarding point 2.2.2: importation of primary packed Medicinal Products in liquid and semi-solid dosage forms: Batch certification only importation of solid dosage forms: only bulk (manufactured by the holder of this authorisation) for visual inspection and sorting to the purposes of exportation again Import of Jardiance 10 mg and 25 mg (Bulkware) by the manufacturer Boehringer Ingelheim Seiyaku Co., Ltd., 5353-1 Higashine Koh, Higashine, Yamagata, 999-3701, Japan

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_NW_05_GMP_2026_0004

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_NW_05_GMP_2026_0004

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.