Eudra GMP - Public Layout

MIA | GMP | API REG | WDA | GDP | Sites

Help

Tue 10 Nov 2026 14:06:25 BST

GMP Compliance Menu

GMP Certificates

Non-Compliance Report

The Certificate has been withdrawn, withdrawn date is : 2026-07-23

Print Preview

Print Preview (Short version)

Back To Search

Landesamt Fuer Gesundheit Und Soziales

CERTIFICATE NUMBER: DE_BE_01_GMP_2023_0075

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: Chemisch-pharmazeutisches Labor Rolf Sachse GmbH

Site address:

Stieffring 14, Charlottenburg, Berlin, 13627, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100013251 / LOC-100022210

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. DE_BE_01_MIA_2022_0053 in accordance with Art. 88 of Regulation (EU) 2019/6.

Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/60.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-06-29 , it is considered that it complies with:

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

The principles of GMP for active substances referred to in Art. 123(6) of Regulation (EU) 2019/6.

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

1.6 Quality control testing

1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

2.1.3 Chemical/Physical

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

[00020455-00002]Atipamezole hydrochloride(en)

[00020455-00003]Clenbuterol hydrochloride(en)

[00020455-00004]Detomidine hydrochloride(en)

[00020455-00005]Halofuginon lactate(en)

[00020455-00006]Medetomidine hydrochloride(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Atipamezole hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
cristalisation and filtration

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying and homogenization

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Clenbuterol hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
crisatlisation and filtration

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying and homogenization

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Detomidine hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
cristalisation and filtration

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying and homogenization

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Halofuginon lactate

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
cristalisation and filtration

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying and homogenization

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Medetomidine hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
cristalisation and filtration

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying and homogenization

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Clarifying remarks (for public users):

to 1.6.3 und 2.1.3: The authorised testing activities do not include batch certification.

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_BE_01_GMP_2026_0035

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_BE_01_GMP_2026_0035

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.