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Landesamt Fuer Soziales Jugend Und Versorgung

CERTIFICATE NUMBER: DE_RP_01_GMP_2025_0003

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: Boehringer Ingelheim Pharma GmbH & Co. KG

Site address: Binger Strasse 173, Ingelheim Am Rhein, Rhineland-Palatinate, 55216

OMS Organisation Id. / OMS Location Id.: ORG-100000199 / LOC-100004370


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  2024-07-11 , 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

    1  MANUFACTURING OPERATIONS
    1.4  Other products or manufacturing activity
       1.4.3  Other: active pharmaceutical ingredients(en)
    1.5  Packaging
       1.5.1  Primary Packaging
               1.5.1.17  Other non-sterile medicinal products: active pharmaceutical ingredients(en)
    1.6  Quality control testing
       1.6.3  Chemical/Physical

    Manufacture of active substance. Names of substances subject to inspection:
    [00022930-00002]Afatinib dimaleate API starting materials: Dimethylaminoacetaldehyde diethylacetal; Diethylphosphonoacetic acid; (S)-3-Hydroxy-tetrahydrofuran; N-(3-chloro-4-fluorophenyl)-6-nitro-7- (phenylsulfonyl)-4-quinazolinamine(en)
    [00022930-00003]Ambroxol API starting material: Ambroxolhydrochloride(en)
    [00022930-00006]Brotizolam API starting materials: 7-Bromo-5-(2-chlorophenyl)-1,3-dihydro- 2H-thieno[2,3e][1,4]-diazepin-2-one; acetic acid hydrazide(en)
    [00022930-00007]N-Butyl-scopolamine bromide API starting materials: Scopolamine; 1-Bromobutane(en)
    [00022930-00009]Clonidine hydrochloride API starting materials: 1-Acetyl-imidazolidin-2-on; 2,6-Dichloranilin(en)
    [00022930-00011]Dabigatran etexilate API starting materials: Chloroformic acid 1-hexyl ester; 3-[(3-Amino-4-methyl-aminobenzoyl)pyridin- 2-yl-amino]propionic acid ethyl ester; [4-(5-Oxo-4,5-dihydro-[1,2,4]oxadiazol-3-yl)- phenylamino]-acetic acid(en)
    [00022930-00016]Empagliflozin API starting materials: Glucono-delta-lactone; (S)-3-Hydroxy-tetrahydrofuran; (2-chloro-5-iodophenyl)(4-fluorophenyl)-methanone(en)
    [00022930-00017]Epinastine hydrochloride API starting material: 6-(2-Phthalimidomethyl)-11H-dibenz[b,e]azepine(en)
    [00022930-00022]Fenoterol hydrobromide API starting materials: 4-Methoxy-alpha-methyl-N-(phenylmethyl)- benzeneethanamine; 3,5-Diacetoxyacetophenone(en)
    [00022930-00028]Ipratropiumbromide API starting materials: Methyl bromide Methyl formiate; Methyl phenylacetate; Acetonedicarboxylic ester; 2,5 dimethoxy-tetrahydrofurane; Isopropylamine(en)
    [00022930-00029]Linagliptin API starting materials: 8-bromo-7-(2-butynyl)-3,7-dihydro-3-methyl- 1H-Purine-2,6-dione; 2-(chloro-methyl)-4-methyl-Quinazoline; 2-(3R)-3-piperidinyl-(2S,3S)-2,3-dihydroxy- butanedioate-1H-Isoindole-1,3(2H)-dione(en)
    [00022930-00034]Nintedanib esilate API starting materials: Methyl 1-(chloroacetyl)-2,3-dihydro-2-oxo-1H- indole-6-carboxylate; Trimethyl orthobenzoate; 2-chloro-N-methyl-N-(4-nitrophenyl)-acetamide; 1-methylpiperazine(en)
    [00022930-00036]Olodaterol hydrochloride API starting materials: 6-Benzyloxy-8-(2-bromoacetyl)-4H-benzo- [1,4]oxazin-3-one; 2-(4-Methoxyphenyl)-1,1- dimethylethylamine HCl(en)
    [00022930-00043]Pramipexol hydrochloride API starting materials: Thiourea; Paracetamol; Propionic anhydride(en)
    [00022930-00044]Repaglinide API starting materials: 3-Ethoxy-4-ethoxy carbonylphenyl acetic acid; sec-butyllithium; 2-Piperidinobenzonitrile(en)
    [00022930-00046]Salbutamol sulfate API starting materials: N-Benzyl-tert-butylamine; 3-Acetoxymethyl-4-acetoxy-acetophenone(en)
    [00022930-00053]Tiotropium bromide API starting materials: Methscopolaminbromide; 2-bromthiophene; Dimethyl oxalate(en)
    [00022930-00054]Tipranavir API starting materials: 5,6-dihydro-4-hydroxy-6-(2-phenylethyl)-6- propyl-(6R)-2H-Pyran-2-one; 1-(3-nitrophenyl)-1-Propanone; 5-(trifluoromethyl)-2(1H)-Pyridinethione(en)
    [00022930-00055]Tramazoline hydrochloride API starting materials: 1-Acetyl-imidazolidin-2-one; 5-Aminotetraline hydrochloride(en)
    [00022930-00056]Iclepertin (BI 425809) 3,3,3-Trifluorpropenyl-2-acetate 2-Fluorbenzoic acid (1R,5R)-3-[(tert-butoxy)carbonyle]-3-azabicyclo[3.1.0]hexane-1 carboxylic acid(en)
    [00022930-00057]Nerandomilast (BI 1015550) 1-Aminocyclobutyl-methanol hydrochloride 2,4-Dichloro-thienopyrimidine 5-Chloro-2-iodopyrimidine (1-tert-Butoxycarbonyl-1,2,3,6-tetrahydropyridin-4-yl)boronic acid-pinacol ester(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:Afatinib dimaleate API starting materials: Dimethylaminoacetaldehyde diethylacetal; Diethylphosphonoacetic acid; (S)-3-Hydroxy-tetrahydrofuran; N-(3-chloro-4-fluorophenyl)-6-nitro-7- (phenylsulfonyl)-4-quinazolinamine
    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:
    salt formation and purification steps
    3.5 General Finishing Steps
     
    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:Ambroxol API starting material: Ambroxolhydrochloride
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    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

    Active Substance:Brotizolam API starting materials: 7-Bromo-5-(2-chlorophenyl)-1,3-dihydro- 2H-thieno[2,3e][1,4]-diazepin-2-one; acetic acid hydrazide
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.4  Other:
    storage and stability only
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:N-Butyl-scopolamine bromide API starting materials: Scopolamine; 1-Bromobutane
    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:
    salt formation and purification steps
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    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

    Active Substance:Clonidine hydrochloride API starting materials: 1-Acetyl-imidazolidin-2-on; 2,6-Dichloranilin
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.4  Other:
    Only stability studies
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Dabigatran etexilate API starting materials: Chloroformic acid 1-hexyl ester; 3-[(3-Amino-4-methyl-aminobenzoyl)pyridin- 2-yl-amino]propionic acid ethyl ester; [4-(5-Oxo-4,5-dihydro-[1,2,4]oxadiazol-3-yl)- phenylamino]-acetic acid
    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:
    salt formation and purification steps
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    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

    Active Substance:Empagliflozin API starting materials: Glucono-delta-lactone; (S)-3-Hydroxy-tetrahydrofuran; (2-chloro-5-iodophenyl)(4-fluorophenyl)-methanone
    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:
    salt formation and purification steps
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    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

    Active Substance:Epinastine hydrochloride API starting material: 6-(2-Phthalimidomethyl)-11H-dibenz[b,e]azepine
    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:
    salt formation and purification steps
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    sieving
    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:Fenoterol hydrobromide API starting materials: 4-Methoxy-alpha-methyl-N-(phenylmethyl)- benzeneethanamine; 3,5-Diacetoxyacetophenone
    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:
    salt formation and purification steps
    3.5 General Finishing Steps
     
    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:Ipratropiumbromide API starting materials: Methyl bromide Methyl formiate; Methyl phenylacetate; Acetonedicarboxylic ester; 2,5 dimethoxy-tetrahydrofurane; Isopropylamine
    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:
    salt formation and purification steps
    3.5 General Finishing Steps
     
    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:Linagliptin API starting materials: 8-bromo-7-(2-butynyl)-3,7-dihydro-3-methyl- 1H-Purine-2,6-dione; 2-(chloro-methyl)-4-methyl-Quinazoline; 2-(3R)-3-piperidinyl-(2S,3S)-2,3-dihydroxy- butanedioate-1H-Isoindole-1,3(2H)-dione
    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:
    salt formation and purification steps
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    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

    Active Substance:Nintedanib esilate API starting materials: Methyl 1-(chloroacetyl)-2,3-dihydro-2-oxo-1H- indole-6-carboxylate; Trimethyl orthobenzoate; 2-chloro-N-methyl-N-(4-nitrophenyl)-acetamide; 1-methylpiperazine
    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:
    salt formation and purification steps
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    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

    Active Substance:Olodaterol hydrochloride API starting materials: 6-Benzyloxy-8-(2-bromoacetyl)-4H-benzo- [1,4]oxazin-3-one; 2-(4-Methoxyphenyl)-1,1- dimethylethylamine HCl
    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:
    salt formation and purification steps
    3.5 General Finishing Steps
     
    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:Pramipexol hydrochloride API starting materials: Thiourea; Paracetamol; Propionic anhydride
    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:
    salt formation and purification steps
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    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

    Active Substance:Repaglinide API starting materials: 3-Ethoxy-4-ethoxy carbonylphenyl acetic acid; sec-butyllithium; 2-Piperidinobenzonitrile
    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:
    salt formation and purification steps
    3.5 General Finishing Steps
     
    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:Salbutamol sulfate API starting materials: N-Benzyl-tert-butylamine; 3-Acetoxymethyl-4-acetoxy-acetophenone
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.4  Other:
    storage and stability studies only
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Tiotropium bromide API starting materials: Methscopolaminbromide; 2-bromthiophene; Dimethyl oxalate
    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:
    salt formation and purification steps
    3.5 General Finishing Steps
     
    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:Tipranavir API starting materials: 5,6-dihydro-4-hydroxy-6-(2-phenylethyl)-6- propyl-(6R)-2H-Pyran-2-one; 1-(3-nitrophenyl)-1-Propanone; 5-(trifluoromethyl)-2(1H)-Pyridinethione
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.4  Other:
    storage and stability studies only
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Tramazoline hydrochloride API starting materials: 1-Acetyl-imidazolidin-2-one; 5-Aminotetraline hydrochloride
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.4  Other:
    storage and stability studies only
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Iclepertin (BI 425809) 3,3,3-Trifluorpropenyl-2-acetate 2-Fluorbenzoic acid (1R,5R)-3-[(tert-butoxy)carbonyle]-3-azabicyclo[3.1.0]hexane-1 carboxylic acid
    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:
    salt formation and purification
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Sieving
    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:Nerandomilast (BI 1015550) 1-Aminocyclobutyl-methanol hydrochloride 2,4-Dichloro-thienopyrimidine 5-Chloro-2-iodopyrimidine (1-tert-Butoxycarbonyl-1,2,3,6-tetrahydropyridin-4-yl)boronic acid-pinacol ester
    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:
    Salt formation and purification
    3.5 General Finishing Steps
     
    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

     

     


    		 
    		 
     
         
     
     
    		 
     
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