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Landesamt Fuer Soziales Jugend Und Versorgung

CERTIFICATE NUMBER: DE_RP_01_GMP_2024_0032

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: Elementis Pharma GmbH

Site address: Giulinistraße 2, Rheingönheim, Ludwigshafen Am Rhein, Rhineland-Palatinate, 67065, Germany

OMS Organisation Id. / OMS Location Id.: ORG-100024502 / LOC-100033675


Has been inspected under the national inspection programme in connection with manufacturing authorisation no.  DE_RP_01_MIA_2021_0037  in accordance with 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).

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  2023-11-29 , it is considered that it complies with:

  • The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)
  • 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
    1.2  Non-sterile products
       1.2.1  Non-sterile products (processing operations for the following dosage forms)
               1.2.1.17  Other: Powder and Suspensions Bulkware -Sucrate Gel S651 -Sucralan S653 -Megalac formulation C657(en)
       1.2.2  Batch certification
    1.6  Quality control testing
       1.6.3  Chemical/Physical

    Manufacture of active substance. Names of substances subject to inspection:
    [00022014-00001]Dried Aluminum Hydroxide Gel (powder) USP, Aluminium Oxide, Hydrated (powder) Algeldrat Ph.Eur., Aluminum Hydroxide Gel (paste/suspension) USP,(en)
    [00022014-00002]Magnesium Hydroxide (powder and paste/suspension) USP/Ph.Eur.(en)
    [00022014-00003]Aluminium Phosphate Gel (paste/suspension) USP, Ph.Eur., Aluminium Phosphate hydrated (powder) Ph.Eur.(en)
    [00022014-00004]Magaldrate (powder and paste/suspension) USP/Ph.Eur.(en)
    [00022014-00005]Aluminium Hydroxide Magnesium Carbonate (powder and paste/suspension)(en)
    [00022014-00006]Dihydroxy Aluminum Sodium Carbonate (powder) DASC; Carbaldrate USP(en)
    [00022014-00007]Hydrotalcite (powder and paste/suspension) Complex Aluminum Magnesium Hydroxy Carbonate BP(en)
    [00022014-00008]Almagate (powder) Hydrated Aluminium Magnesium Hydroxy Carbonat Ph.Eur.(en)
    [00022014-00009]Sucralfate (powder and paste/suspension) Aluminium Sucroseoctasulfate, hydrated USP/Ph.Eur(en)
    [00022014-00010]Aluminium-Magnesium-Hydroxide paste C641(en)
    [00022014-00011]Aluminium-Magnesium-Hydroxide-Coblend Gel C655(en)
    [00022014-00012]Aluminum-dichlorohydrate (powder) A292 USP(en)
    [00022014-00013]Magnesium Silikate (powder) D311(en)
    [00022014-00014]Aluminium Magnesium Silicate Powder and Paste(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:Dried Aluminum Hydroxide Gel (powder) USP, Aluminium Oxide, Hydrated (powder) Algeldrat Ph.Eur., Aluminum Hydroxide Gel (paste/suspension) USP,
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Magnesium Hydroxide (powder and paste/suspension) USP/Ph.Eur.
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Aluminium Phosphate Gel (paste/suspension) USP, Ph.Eur., Aluminium Phosphate hydrated (powder) Ph.Eur.
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Magaldrate (powder and paste/suspension) USP/Ph.Eur.
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Aluminium Hydroxide Magnesium Carbonate (powder and paste/suspension)
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Dihydroxy Aluminum Sodium Carbonate (powder) DASC; Carbaldrate USP
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Hydrotalcite (powder and paste/suspension) Complex Aluminum Magnesium Hydroxy Carbonate BP
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Almagate (powder) Hydrated Aluminium Magnesium Hydroxy Carbonat Ph.Eur.
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Sucralfate (powder and paste/suspension) Aluminium Sucroseoctasulfate, hydrated USP/Ph.Eur
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Aluminium-Magnesium-Hydroxide paste C641
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Aluminium-Magnesium-Hydroxide-Coblend Gel C655
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Aluminum-dichlorohydrate (powder) A292 USP
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Magnesium Silikate (powder) D311
    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:
    N/A
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:Aluminium Magnesium Silicate Powder and Paste
    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:
    N/A
    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_RP_01_GMP_2025_0002
    Withdrawal comments in National Language: Das GMP-Zertifikat wurde ersetzt durch das Dokument mit der Nummer DE_RP_01_GMP_2025_0002

    		 
    		 
     
         
     
     
    		 
     
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