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The Certificate has been withdrawn, withdrawn date is : 2026-09-18

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Bezirksregierung Detmold

CERTIFICATE NUMBER: DE_NW_02_GMP_2024_0022

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: Siegfried PharmaChemikalien Minden GmbH

Site address:

Karlstrasse 15-39, Innenstadt, Minden, North Rhine-Westphalia, 32423, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100012159 / LOC-100022673

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 2023-04-21 , it is considered that it complies with:

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

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

[00022019-00001](-)-Ephedrine-Hydrochloride(en)

[00022019-00002](-)-Ephedrine-Sulfate(en)

[00022019-00003](+)-Pseudoephedrine-Hydrochloride(en)

[00022019-00004](+)-Pseudoephedrine-Sulfate(en)

[00022019-00006]Aminophyllin anhydrous(en)

[00022019-00007]Aminophyllin hydrous(en)

[00022019-00008]Amylmetacrosol(en)

[00022019-00011]Caffeine anhydrous(en)

[00022019-00013]Dobutamine-Hydrochloride(en)

[00022019-00014]Dopamine-Hydrochloride(en)

[00022019-00015]Isotretinoin(en)

[00022019-00016]Oxymetazoline-Hydrochloride(en)

[00022019-00017]Phenylephrine-Hydrochloride(en)

[00022019-00024]Theophylline hydrous(en)

[00022019-00025]trans-Tilidin-Hydrochloride Hemihydrat(en)

[00022019-00026]Tretinoin(en)

[00022019-00027]Xylometazoline-Hydrochloride(en)

[00022019-00029]Theophyllin anhydrous(en)

[00022019-00030]Naloxone-Hydrochloride(en)

[00022019-00031]Naltrexone-Hydrochloride(en)

[00022019-00032]Buprenorphine hydrochlorid(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:(-)-Ephedrine-Hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:(-)-Ephedrine-Sulfate

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:(+)-Pseudoephedrine-Hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:(+)-Pseudoephedrine-Sulfate

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Aminophyllin anhydrous

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Aminophyllin hydrous

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Amylmetacrosol

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Caffeine anhydrous

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Dobutamine-Hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Dopamine-Hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Isotretinoin

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Oxymetazoline-Hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Phenylephrine-Hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Theophylline hydrous

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:trans-Tilidin-Hydrochloride Hemihydrat

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Tretinoin

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Xylometazoline-Hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Theophyllin anhydrous

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Naloxone-Hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Naltrexone-Hydrochloride

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:Buprenorphine hydrochlorid

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.4  Other:
Synthetic-chemical manufacturing all steps including purification up to API

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Clarifying remarks (for public users):

The site also includes the house numbers Karlstrasse 42-44, 32423 Minden (LOC-100066434)

Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_NW_02_GMP_2026_0011

Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_NW_02_GMP_2026_0011

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