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Health And Youth Care Inspectorate

CERTIFICATE NUMBER: NL/H 23/2050751

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 Netherlands confirms the following:

The manufacturer: Laboratorium Ofichem B.V.

Site address:

Heembadweg 5, Ter Apel, 9561 CZ, Netherlands

OMS Organisation Id. / OMS Location Id.: ORG-100018999 / LOC-100027763

Has been inspected under the national inspection programme in accordance with Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Art. 100 of the Medicines Act.

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:Art. 100 of the Medicines Act.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-10-10 , 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:Art. 100 of the Medicines 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:

[75]PAMIDRONIC ACID(en)

[77]DIMETHYLFUMARATE(en)

[81]SULFADIAZINE SODIUM(en)

[82]SULFADIMIDINE SODIUM(en)

[83]SULFATHIAZOLE SODIUM HEXAHYDRATE(en)

[84]SULFADIMETHOXINE SODIUM(en)

[87]LEVAMISOLE BASE(en)

[1002]COLLISTINE SULFATE(en)

[1007]DISODIUM PAMIDRONATE PENTAHYDRATE(en)

FORMIC ACID(en)

HISTAMINE DIHYDROCHLORIDE(en)

[1011]HISTAMINE PHOSPHATE(en)

OXALIC ACID(en)

PIPERAZINE CITRATE(en)

PHTHALYLSULFATHIAZOLE(en)

SILVER NITRATE(en)

ZINC ACETATE(en)

[1074]CALCIUM MONOETHYLFUMARATE(en)

CANNABIDIOL(en)

[1078]EDETATE CALCIUM DISODIUM(en)

[1079]GUANABENZ ACETATE(en)

[1060]MAGNESIUM MONOETHYLFUMARATE(en)

METHENAMINE MANDELATE(en)

[1061]OFIBIDIOL(en)

[1062]OFIBINIOL(en)

[1063]OFICAN(en)

[1064]PALMITOYLETHANOLAMIDE(en)

[1065]PHENTOLAMINE MESYLATE(en)

POTASSIUM BROMIDE(en)

[1066]BETAHYDROXYBUTYRATE SALTS(en)

[1070]S-REBOXETINE SUCCINATE(en)

[1071]TETRAHYDROCANNABIDIOL(en)

[1073]ZINC MONOETHYLFUMARATE(en)

[NL24/01]2C-B(en)

2-DEOXY-D-GLUCOSE(en)

[NL24/02]5-METHOXY DIMETHYLTRYPTAMINE(en)

ALMOTRIPTAN(en)

[NL24/03]DIMETHYLTRYPTAMINE HEMIFUMARATE(en)

[NL24/04]EDETATE DISODIUM(en)

L-FUCOSE(en)

[NL24/05]LSD AND SALTS(en)

[NL24/06]MDMA AND SALTS(en)

NAPHAZOLINE(en)

[NL24/07]PHENYLACETYL DISULFIDE(en)

SODIUM BENZOATE(en)

[NL24/09]SODIUM PHENYL ACETATE(en)

[NL24/10]SUL-238(en)

SULFADIMETHOXINE SODIUM(en)

[NL24/11]SULFATHIAZOLE SODIUM PENTAHYDRATE(en)

[NL24/12]VITAMIN A (RETINOL)(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:PAMIDRONIC ACID

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing

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:DIMETHYLFUMARATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing/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:SULFADIAZINE SODIUM

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Salt formation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing/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:SULFADIMIDINE SODIUM

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Salt formation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing/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:SULFATHIAZOLE SODIUM HEXAHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Salt Formation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing/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:SULFADIMETHOXINE SODIUM

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Salt formation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing/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:LEVAMISOLE BASE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Salt formation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing/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:COLLISTINE SULFATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Salt formation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing

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:DISODIUM PAMIDRONATE PENTAHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing

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:FORMIC ACID

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Purification

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Mixing

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:HISTAMINE DIHYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing

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:HISTAMINE PHOSPHATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing

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:OXALIC ACID

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Purification

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing/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:PIPERAZINE CITRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing/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:PHTHALYLSULFATHIAZOLE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing/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:SILVER NITRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing

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 ACETATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/Mixing

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 MONOETHYLFUMARATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying/mixing/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

Active Substance:CANNABIDIOL

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.2 Extraction of Active Substance from Natural Sources

3.2.5  Modification of extracted substance Plant

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying/mixing

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:EDETATE CALCIUM DISODIUM

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
cristalization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying/mixing/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:GUANABENZ ACETATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying/mixing/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

Active Substance:MAGNESIUM MONOETHYLFUMARATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying/mixing/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

Active Substance:METHENAMINE MANDELATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying/mixing/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:OFIBIDIOL

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

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:
drying/mixing

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)

3.5.4  Other:
dilution in MCT oil

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:OFIBINIOL

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

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:
drying/mixing

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)

3.5.4  Other:
dilution in MCT oil

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:OFICAN

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

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:
drying/mixing

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)

3.5.4  Other:
dilution in MCT oil

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:PALMITOYLETHANOLAMIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
cristalization

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:PHENTOLAMINE MESYLATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
cristalization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying/mixing/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

Active Substance:POTASSIUM BROMIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying/mixing/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:BETAHYDROXYBUTYRATE SALTS

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying/mixing/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:S-REBOXETINE SUCCINATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
cristalization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying/mixing/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:TETRAHYDROCANNABIDIOL

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.2 Extraction of Active Substance from Natural Sources

3.2.5  Modification of extracted substance Plant

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying/mixing

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 MONOETHYLFUMARATE

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying/mixing

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:2C-B

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing/milling/micronizing/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:2-DEOXY-D-GLUCOSE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Salt formation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing

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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:5-METHOXY DIMETHYLTRYPTAMINE

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing/milling/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:ALMOTRIPTAN

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:DIMETHYLTRYPTAMINE HEMIFUMARATE

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing/milling/micronizing/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:EDETATE DISODIUM

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing/milling/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:L-FUCOSE

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing

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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:LSD AND SALTS

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing/milling/micronizing/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:MDMA AND SALTS

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing/milling/micronizing/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:NAPHAZOLINE

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying.mixing/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:PHENYLACETYL DISULFIDE

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing

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:SODIUM BENZOATE

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing/milling/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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:SODIUM PHENYL ACETATE

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing and 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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:SUL-238

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

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and mixing

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

3.6.2  Microbiological testing excluding sterility testing

Active Substance:SULFADIMETHOXINE SODIUM

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Salt formation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing and 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:SULFATHIAZOLE SODIUM PENTAHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Salt formation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing and 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:VITAMIN A (RETINOL)

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying/mixing/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

4. Other Activities - Active Substances:
-

Withdrawal comments in English: This certificate is been replaced by NL/API 26/2062232B

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