Eudra GMP - Public Layout

MIA | GMP | API REG | WDA | GDP | Sites

Help

Mon 9 Nov 2026 12:31:39 BST

GMP Compliance Menu

GMP Certificates

Non-Compliance Report

The Certificate has been withdrawn, withdrawn date is : 2024-06-17

Print Preview

Print Preview (Short version)

Back To Search

State Institute For Drug Control

CERTIFICATE NUMBER: SK/017V/2023

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Slovakia confirms the following:

The manufacturer: Saneca Pharmaceuticals a.s.

Site address:

Nitrianska 100, Hlohovec, 920 01, Slovakia

OMS Organisation Id. / OMS Location Id.: ORG-100002257 / LOC-100000752

DUNS Number: 36-717-7816

Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC0.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2023-09-28 , it is considered that it complies with:

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

Part 2

Human Medicinal Products

Manufacture of active substance. Names of substances subject to inspection:

[11009]L-ASPARTIC ACID POTASIUM MAGNESIUM SALT(en)

[10991]ATORVASTATIN CALCIUM SALT(en)

[11010]SODIUM STEARYL FUMARATE(en)

[11306]BENZYLPETHIDINE BASE(en)

[10986]FENIPENTOL(en)

[11003]PENTOXIFYLLINE(en)

[10983]ETOFYLLINE(en)

[10984]DOXAZOSIN MESYLATE(en)

[10981]TRAMADOL HYDROCHLORIDE(en)

[11005]RIVASTIGMINE HYDROGENTARTRATE(en)

[11002]DULOXETINE HYDROCHLORIDE(en)

[11312]MORPHINE SULPHATE(en)

[11012]MORPHINE BASE(en)

[11313]OXYCODONE HYDROCHLORIDE(en)

[11314]PETHIDINE HYDROCHLORIDE(en)

[11006]HYDROMORPHONE HYDROCHLORIDE(en)

[11308]CODEINE PHOSPHATE HEMIHYDRATE(en)

[11309]DIHYDROCODEINE HYDROGEN TARTRATE(en)

[11310]FENTANYL CITRATE(en)

[11311]METHADONE HYDROCHLORIDE(en)

[11307]CODEINE BASE(en)

[11635]PHOLCODINE(en)

NALTREXONE(en)

HYDROCODONE BITARTRATE(en)

DIHYDROCODEINE PHOSPHATE(en)

[10000000099523]NALBUPHINE HYDROCHLORIDE(en)

MIRABEGRON(en)

NALMEFENE(en)

NALOXONE(en)

TRIHEXYPHENIDYL(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:L-ASPARTIC ACID POTASIUM MAGNESIUM SALT

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
filtration

3.5 General Finishing Steps

3.5.1  Physical processing steps:
filtration

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:ATORVASTATIN CALCIUM SALT

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.3  Salt formation / Purification steps:
precipitation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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 STEARYL FUMARATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.3  Salt formation / Purification steps:
precipitation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:BENZYLPETHIDINE BASE

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

3.1.4  Other:
crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:FENIPENTOL

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

3.1.4  Other:
distillation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
filtration

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:PENTOXIFYLLINE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.4  Other:
crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:ETOFYLLINE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.4  Other:
crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:DOXAZOSIN MESYLATE

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:
crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:TRAMADOL HYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:RIVASTIGMINE HYDROGENTARTRATE

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:
crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:DULOXETINE HYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:MORPHINE SULPHATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.2  Manufacture of crude active substance
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.3  Salt formation / Purification steps:
crystallisation

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, sieving

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
Special Requirements:
7.Other:
narcotic and psychotropic 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)
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6.2  Microbiological testing excluding sterility testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

Active Substance:MORPHINE BASE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.2  Manufacture of crude active substance
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.4  Other:
precipitation

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.2 Extraction of Active Substance from Natural Sources

3.2.1  Extraction of substance from plant source
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.2.6  Purification of extracted substance Plant
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
Special Requirements:
7.Other:
narcotic and psychotropic 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)
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6.2  Microbiological testing excluding sterility testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

Active Substance:OXYCODONE HYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.2  Manufacture of crude active substance
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.3  Salt formation / Purification steps:
crystallisation

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, sieving

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
Special Requirements:
7.Other:
narcotic and psychotropic 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)
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6.2  Microbiological testing excluding sterility testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

Active Substance:PETHIDINE HYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.2  Manufacture of crude active substance
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.3  Salt formation / Purification steps:
crystallisation

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, sieving

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
Special Requirements:
7.Other:
narcotic and psychotropic 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)
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6.2  Microbiological testing excluding sterility testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

Active Substance:HYDROMORPHONE HYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.3  Salt formation / Purification steps:
crystallisation

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, sieving

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
Special Requirements:
7.Other:
narcotic and psychotropic 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)
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6.2  Microbiological testing excluding sterility testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

Active Substance:CODEINE PHOSPHATE HEMIHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.2  Manufacture of crude active substance
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.3  Salt formation / Purification steps:
crystallisation

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, sieving

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
Special Requirements:
7.Other:
narcotic and psychotropic 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)
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6.2  Microbiological testing excluding sterility testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

Active Substance:DIHYDROCODEINE HYDROGEN TARTRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.2  Manufacture of crude active substance
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.3  Salt formation / Purification steps:
crystallisation

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, sieving

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
Special Requirements:
7.Other:
narcotic and psychotropic 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)
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6.2  Microbiological testing excluding sterility testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

Active Substance:FENTANYL CITRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.2  Manufacture of crude active substance
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.3  Salt formation / Purification steps:
crystallisation

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, sieving

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
Special Requirements:
7.Other:
narcotic and psychotropic 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)
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6.2  Microbiological testing excluding sterility testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

Active Substance:METHADONE HYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.2  Manufacture of crude active substance
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.3  Salt formation / Purification steps:
crystallisation

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, sieving

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
Special Requirements:
7.Other:
narcotic and psychotropic 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)
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6.2  Microbiological testing excluding sterility testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

Active Substance:CODEINE BASE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.4  Other:
precipitation

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, sieving

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
Special Requirements:
7.Other:
narcotic and psychotropic 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)
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6.2  Microbiological testing excluding sterility testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

Active Substance:PHOLCODINE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.2  Manufacture of crude active substance
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.4  Other:
crystallisation

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifugation, drying, sieving

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
Special Requirements:
7.Other:
narcotic and psychotropic 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)
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6.2  Microbiological testing excluding sterility testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

Active Substance:NALTREXONE

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:
crystalisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:HYDROCODONE BITARTRATE

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:
crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:DIHYDROCODEINE PHOSPHATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.2  Manufacture of crude active substance
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.1.3  Salt formation / Purification steps:
crystallisation

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, sieving

Special Requirements:
7.Other:
narcotic and psychotropic substance

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
Special Requirements:
7.Other:
narcotic and psychotropic 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)
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

3.6.2  Microbiological testing excluding sterility testing
Special Requirements:
7.Other:
narcotic and psychotropic substance

Active Substance:NALBUPHINE HYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:MIRABEGRON

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

3.1.4  Other:
crystalisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:NALMEFENE

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:
crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:NALOXONE

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:
crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
centrifuging, drying, 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:TRIHEXYPHENIDYL

3.5 General Finishing Steps

3.5.1  Physical processing steps:
milling/ micronisation

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

Withdrawal comments in English: correction of the scope of the certificate

Withdrawal comments in National Language: oprava rozsahu certifikátu

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.