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State Institute For Drug Control

CERTIFICATE NUMBER: sukls234924/2023

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 Czechia confirms the following:

The manufacturer: Macco Organiques s.r.o.

Site address:

Zahradni 46c/1938, Bruntal 1, 792 01

OMS Organisation Id. / OMS Location Id.: ORG-100017613 / LOC-100037059

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:Section 101 paragraph 3 of the Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-10-31 , 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:Section 101 paragraph 3 of the Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended.

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:

[716971697]AMMONIUM SULFATE CAS 7783-20-2(en)

[71050560]CALCIUM CHLORIDE DIHYDRATE CAS 10035-04-8(en)

[719676979]POTASSIUM CHLORIDE CAS 7447-40-7(en)

[87169871687176971]POTASSIUM SULFATE CAS 7778-80-5(en)

[74168769]MAGNESIUM CHLORIDE HEXAHYDRATE CAS 7791-18-6(en)

[7416876968416]MAGNESIUM CHLORIDE 4,5-HYDRATE CAS 56491-84-0(en)

[7441687189789]MAGNESIUM SULFATE HEPTAHYDRATE CAS 10034-99-8(en)

[416876]MAGNESIUM SULFATE X-HYDRATE CAS 22189-08-8(en)

[416876718768]SODIUM SULFATE CAS 7757-82-6(en)

[4168767185566]ZINC SULFATE HEPTAHYDRATE CAS 7446-20-0(en)

[19716987169]ZINC SULFATE MONOHYDRATE CAS 7446-19-7(en)

[197169871717671+]POTASSIUM CHLORIDE CAS 7447-40-7(en)

[8167816917]MAGNESIUM CHLORIDE 4,5 - HYDRATE CAS 56491-84-0(en)

[1744777]MAGNESIUM SULFATE HEPTAHYDRATE CAS 10034-99-8(en)

[174477716]MAGNESIUM SULFATE X-HYDRATE CAS 22189-08-8(en)

[51498716416]SODIUM ACETATE TRIHYDRATE CAS 6131-90-4(en)

[416186403430463]SODIUM HYDROGEN CARBONATE CAS 144-55-8(en)

[5416719791]SODIUM CHLORIDE CAS 7647-14-5(en)

[418971697169]SODIUM SULFATE CAS 7757-82-6(en)

[47681768]ZINC SULFATE HEPTAHYDRATE CAS 7446-20-0(en)

[47681768197]ZINC SULFATE MONOHYDRATE CAS 7446-19-7(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:AMMONIUM SULFATE CAS 7783-20-2

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
eaching, refining, filtration, pH adjustment, evaporation, crystallisation, centrifugation

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:CALCIUM CHLORIDE DIHYDRATE CAS 10035-04-8

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
leaching, oxidation, neutralization, pH adjustment, filtration, evaporation, crystallisation, centr

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

3.6.4  Biological Testing

Active Substance:POTASSIUM CHLORIDE CAS 7447-40-7

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
manufacturing of liquor, debromation, filtration, pH adjustment, evaporation, crystallisation, sepa

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

3.6.4  Biological Testing

Active Substance:POTASSIUM SULFATE CAS 7778-80-5

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
leaching and refining, filtration, pH adjustment, evaporation, crystallization, centrifugation

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:MAGNESIUM CHLORIDE HEXAHYDRATE CAS 7791-18-6

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
leaching, oxidation, neutralization, filtration, pH adjustment, evaporation, crystallisation, centr

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

3.6.4  Biological Testing

Active Substance:MAGNESIUM CHLORIDE 4,5-HYDRATE CAS 56491-84-0

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
leaching, oxidation, neutralization, pH adjustment, filtration, evaporation, crystallisation, centr

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

3.6.4  Biological Testing

Active Substance:MAGNESIUM SULFATE HEPTAHYDRATE CAS 10034-99-8

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
manufacturing of liquor, filtration, pH adjustment, evaporation, crystallisation, centrifugation

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

3.6.4  Biological Testing

Active Substance:MAGNESIUM SULFATE X-HYDRATE CAS 22189-08-8

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
výroba roztoku, filtrace, úprava pH, odpařování, krystalizace, odstřeďování

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

3.6.4  Biological Testing

Active Substance:SODIUM SULFATE CAS 7757-82-6

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Dissolving of crude Sodium Sulfate, pH adjustment, removal of heavy metals, filtration of mechanica

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:ZINC SULFATE HEPTAHYDRATE CAS 7446-20-0

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
manufacturing of liquor, cementation, filtration, pH adjustment, evaporation, crystallization, cent

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:ZINC SULFATE MONOHYDRATE CAS 7446-19-7

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
manufacturing of liquor, cementation, filtration, pH adjustment, evaporation, crystallization, cent

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:POTASSIUM CHLORIDE CAS 7447-40-7

3.5 General Finishing Steps

3.5.1  Physical processing steps:
grinding

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)

Active Substance:MAGNESIUM CHLORIDE 4,5 - HYDRATE CAS 56491-84-0

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)

Active Substance:MAGNESIUM SULFATE HEPTAHYDRATE CAS 10034-99-8

3.5 General Finishing Steps

3.5.1  Physical processing steps:
grinding

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)

Active Substance:MAGNESIUM SULFATE X-HYDRATE CAS 22189-08-8

3.5 General Finishing Steps

3.5.1  Physical processing steps:
grinding, 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)

Active Substance:SODIUM ACETATE TRIHYDRATE CAS 6131-90-4

3.5 General Finishing Steps

3.5.1  Physical processing steps:
grinding

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

3.6.4  Biological Testing

Active Substance:SODIUM HYDROGEN CARBONATE CAS 144-55-8

3.5 General Finishing Steps

3.5.1  Physical processing steps:
grinding

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

3.6.4  Biological Testing

Active Substance:SODIUM CHLORIDE CAS 7647-14-5

3.5 General Finishing Steps

3.5.1  Physical processing steps:
grinding

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)

Active Substance:SODIUM SULFATE CAS 7757-82-6

3.5 General Finishing Steps

3.5.1  Physical processing steps:
grinding

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)

Active Substance:ZINC SULFATE HEPTAHYDRATE CAS 7446-20-0

3.5 General Finishing Steps

3.5.1  Physical processing steps:
grinding

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)

Active Substance:ZINC SULFATE MONOHYDRATE CAS 7446-19-7

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)

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.