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Landesamt Fuer Arbeitsschutz Verbraucherschutz Und Gesundheit

CERTIFICATE NUMBER: DE_BB_01_GMP_2024_0024

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: Chiracon GmbH

Site address: Im Biotechnologiepark 9, Luckenwalde, Brandenburg, 14943, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100019150 / LOC-100079717


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  2023-10-13 , 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:
    [00021685-00002]Aminoquinuride-dihydrochloride-heptahemihydrate (Aminochinuride)(en)
    [00021685-00003]4, 17 ss-Dihydroxy-4-androstene-3-one (4,17 ss-Dihydroxy-4-androsten-3-one)(en)
    [00021685-00004][3-(N-Hydroxyformamido)propyl]- phosphonic acid mono sodium salt (Fosmidomycine)(en)
    [00021685-00005](2S)-2-amino-alpha,beta,beta-trideutero-3- (3,4-dihydroxyphenyl) propanoic acid (D2/D3-Levodopa)(en)
    [00021685-00006]3,4-Diaminopyridine (Amifampridine)(en)
    [00021685-00007]4-Aminopyridine (Fampridine)(en)
    [00021685-00008]5-Amino-4-oxopentanic acid hydrochloride (Aminolevulinic acid hydrochloride)(en)
    [00021685-00010]8-Hydroxyquinoline hemisulfate hemihydrate (Oxyquinolin sulfate)(en)
    [00021685-00011]D,L-Lysine acetylsalicylate + Glycine (LASAG)(en)
    [00021685-00012]4-Dimethylaminophenole hydrochloride (Dimethylaminophenol hydrochloride)(en)
    [00021685-00013]2-((1R,6R)-3-methyl-6-(prop-1-en-2-yl)cyclohex- 2-enyl)-5-pentylbenzene-1,3-diol) (Cannabidiole)(en)
    [00021685-00014]3,17-alpha-Dihydroxy-1,3,5(10)-estratriene (Alfatradiol)(en)
    [00021685-00015]3,4-Diamino pyridine dihydrochlorid (Amifampridine dihydrochloride, Amifampridine)(en)
    [00021685-00016]3'-Azido-3'deoxy-5'-thymidylic acid, mono [3-(dodecylthio)-2-decyloxypropyl] ester, sodium salt (Fozivudine)(en)
    [00021685-00017](7R,8R,9R)-8-hydroxy-7-(2-methoxyethoxy)-2,3-dimethyl-9-phenyl-7,8,9,10-tetrahydroimidazo[1,2-h][1,7]naphthyridine (Soraprazane)(en)
    [00021685-00018]6-fluoro-9-methyl-ss-carboline (AC 102)(en)
    [00021685-00019]Imidazolyl ethanamide petanedioic acid (Myelo 101)(en)
    [00021685-00020]3,4-Diaminopyridine Phosphate (Amifampridine phosphate)(en)
    [00021685-00021]Methyl-5-amino-4-oxopentanoate hydrochloride (Aminolevulinic acid methyl ester)(en)
    [00021685-00022]Benfooxythiamine mono Sodium (Benfooxythiamine mono Sodium)(en)
    [00021685-00023]Hexyl-5-amino-4-oxopentanoat hydrochloride (Aminolevulinic acid hexyl ester)(en)
    [00021685-00024](S)-4a-Hydroxy-2-methyl-7-(4-morpholinophenyl) -4a,5,6,7-tetrahydro-4Hpyrrolo[ 2,3-b]thieno[3,2-e]pyridin-4-one (MPH-220)(en)
    [00021685-00025]Verteporfin (1:1)(en)
    [00021685-00026]Bismuth-1,2-ethanedithiol(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:Aminoquinuride-dihydrochloride-heptahemihydrate (Aminochinuride)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:4, 17 ss-Dihydroxy-4-androstene-3-one (4,17 ss-Dihydroxy-4-androsten-3-one)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    steroid hormone
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    steroid hormone
    3.1.3  Salt formation / Purification steps:
    recrystallization
    Special Requirements:
    7.Other:
    steroid hormone
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    Special Requirements:
    7.Other:
    steroid hormone
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    Special Requirements:
    7.Other:
    steroid hormone
    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)
    Special Requirements:
    7.Other:
    steroid hormone
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing
    Special Requirements:
    7.Other:
    steroid hormone

    Active Substance:[3-(N-Hydroxyformamido)propyl]- phosphonic acid mono sodium salt (Fosmidomycine)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:(2S)-2-amino-alpha,beta,beta-trideutero-3- (3,4-dihydroxyphenyl) propanoic acid (D2/D3-Levodopa)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:3,4-Diaminopyridine (Amifampridine)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:4-Aminopyridine (Fampridine)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:5-Amino-4-oxopentanic acid hydrochloride (Aminolevulinic acid hydrochloride)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:8-Hydroxyquinoline hemisulfate hemihydrate (Oxyquinolin sulfate)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:D,L-Lysine acetylsalicylate + Glycine (LASAG)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:4-Dimethylaminophenole hydrochloride (Dimethylaminophenol hydrochloride)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    recrystallisation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:2-((1R,6R)-3-methyl-6-(prop-1-en-2-yl)cyclohex- 2-enyl)-5-pentylbenzene-1,3-diol) (Cannabidiole)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:3,17-alpha-Dihydroxy-1,3,5(10)-estratriene (Alfatradiol)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:3,4-Diamino pyridine dihydrochlorid (Amifampridine dihydrochloride, Amifampridine)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:3'-Azido-3'deoxy-5'-thymidylic acid, mono [3-(dodecylthio)-2-decyloxypropyl] ester, sodium salt (Fozivudine)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    recrystallization
    Special Requirements:
    7.Other:
    High pressure liquid Chromatography (HPLC)
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:(7R,8R,9R)-8-hydroxy-7-(2-methoxyethoxy)-2,3-dimethyl-9-phenyl-7,8,9,10-tetrahydroimidazo[1,2-h][1,7]naphthyridine (Soraprazane)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:6-fluoro-9-methyl-ss-carboline (AC 102)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:Imidazolyl ethanamide petanedioic acid (Myelo 101)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:3,4-Diaminopyridine Phosphate (Amifampridine phosphate)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    recystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:Methyl-5-amino-4-oxopentanoate hydrochloride (Aminolevulinic acid methyl ester)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:Benfooxythiamine mono Sodium (Benfooxythiamine mono Sodium)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:Hexyl-5-amino-4-oxopentanoat hydrochloride (Aminolevulinic acid hexyl ester)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:(S)-4a-Hydroxy-2-methyl-7-(4-morpholinophenyl) -4a,5,6,7-tetrahydro-4Hpyrrolo[ 2,3-b]thieno[3,2-e]pyridin-4-one (MPH-220)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    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

    Active Substance:Verteporfin (1:1)
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.1.4  Other:
    drying
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying
    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

    Active Substance:Bismuth-1,2-ethanedithiol
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    recrystallization
    3.1.4  Other:
    drying
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    micronization
    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

     

     

    Withdrawal comments in English: GMP certificate has been superseded by document with the number DE_BB_01_GMP_2026_0013
    Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_BB_01_GMP_2026_0013

    		 
    		 
     
         
     
     
    		 
     
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