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Austrian Federal Office For Safety In Health Care

CERTIFICATE NUMBER: 480253-103537375

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
Art. 94(1) of Regulation (EU) 2019/6 as amended

The competent authority of Austria confirms the following:

The manufacturer: Loba biotech GmbH

Site address:

Fehrgasse 7, Fischamend, 2401

OMS Organisation Id. / OMS Location Id.: ORG-100020850 / LOC-100029565

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 480253 in accordance with Art. 88 of Regulation (EU) 2019/6 and Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:§ 63 Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/6 and Art. 111(1) of Directive 2001/83/EC1 transposed in the following national legislation:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-11-15 , 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 and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)

The principles of GMP for active substances referred to in Art. 123(6) of Regulation (EU) 2019/6 and 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:§ 63a Medicines Act (Arzneimittelgesetz) and Ordinance 2009 (Arzneimittelbetriebsordnung 2009).

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/EC and Art. 80(5) of Directive 2001/82/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
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.4 Other products or manufacturing activity

1.4.3 Other: Lagerung von Zellbanken/ storage of cell banks(en)

2 IMPORTATION OF MEDICINAL PRODUCTS

2.2 Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
           2.2.1.2  Terminally sterilised
   2.2.2  Non-sterile products
   2.2.3  Biological medicinal products
           2.2.3.5  Biotechnology products

2.3 Other importation activities

2.3.1 Site of physical importation

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

[900000005337]Naphazoline hydrochloride(en)

[900000005338]Naphazoline nitrate(en)

[900000005331]Dexamethasone-21-isonicotinate(en)

[900000005332]Dihydrocodeine hydrochloride(en)

[900000005333]Melarsen oxide(en)

[900000005335]Methanthelinium bromide(en)

[900000005336]Nabilone(en)

[900000005342]3,4-Diaminopyridine(en)

[900000005340]Tetrabenazine(en)

[900000005334]Melarsomine dihydrochloride(en)

[900000005692]Die vollständige Liste der hergestellten und/oder in Verkehr gebrachten und/oder importierten Wirkstoffe ist dem Bundesamt für Sicherheit im Gesundheitswesen (BASG/AGES) bekannt / The complete list of manufactured and/or distributed and/or imported active substances is available at the Austrian Federal Office for Safety in Healthcare (BASG/AGES) - 2(en)

Peginterferon alfa-2a(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Naphazoline 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:
Extraktion, Fällung, Zentrifugation, Umkristallisation, Filtration, Trocknen / Extraction, Precipit…

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

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

3.6.4  Biological Testing

Active Substance:Naphazoline nitrate

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:
Extraktion, Fällung, Zentrifugation, Umkristallisation, Filtration, Trocknen / Extraction, Precipit…

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

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

3.6.4  Biological Testing

Active Substance:Dexamethasone-21-isonicotinate

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:
Extraktion, Fällung, Zentrifugation, Umkristallisation, Filtration, Trocknen / Extraction, Precipit…

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

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

3.6.4  Biological Testing

Active Substance:Dihydrocodeine 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:
Extraktion, Fällung, Zentrifugation, Umkristallisation, Filtration, Trocknen / Extraction, Precipit…

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

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

3.6.4  Biological Testing

Active Substance:Melarsen oxide

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:
Extraktion, Fällung, Zentrifugation, Umkristallisation, Filtration, Trocknen / Extraction, Precipit…

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

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

3.6.4  Biological Testing

Active Substance:Methanthelinium bromide

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:
Extraktion, Fällung, Zentrifugation, Umkristallisation, Filtration, Trocknen / Extraction, Precipit…

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

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

3.6.4  Biological Testing

Active Substance:Nabilone

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:
Extraktion, Fällung, Zentrifugation, Umkristallisation, Filtration, Trocknen / Extraction, Precipit…

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

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

3.6.4  Biological Testing

Active Substance:3,4-Diaminopyridine

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:
Extraktion, Fällung, Zentrifugation, Umkristallisation, Filtration, Trocknen / Extraction, Precipit…

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

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

3.6.4  Biological Testing

Active Substance:Tetrabenazine

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:
Extraktion, Fällung, Zentrifugation, Umkristallisation, Filtration, Trocknen / Extraction, Precipit…

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

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

3.6.4  Biological Testing

Active Substance:Melarsomine dihydrochloride

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:
Extraktion, Fällung, Zentrifugation, Umkristallisation, Filtration, Trocknen / Extraction, Precipit…

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Trocknen, mechanische Aufbereitung / Drying, mechanical processing

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

3.6.4  Biological Testing

Active Substance:Die vollständige Liste der hergestellten und/oder in Verkehr gebrachten und/oder importierten Wirkstoffe ist dem Bundesamt für Sicherheit im Gesundheitswesen (BASG/AGES) bekannt / The complete list of manufactured and/or distributed and/or imported active substances is available at the Austrian Federal Office for Safety in Healthcare (BASG/AGES) - 2

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Active Substance:Peginterferon alfa-2a

3.3 Manufacturing of Active Substance using Biological Processes

3.3.1  Fermentation

3.3.2  Cell Culture:
bacterial/E. coli

3.3.3  Isolation / Purification

3.3.4  Modification

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

3.6.2  Microbiological testing excluding sterility testing

3.6.4  Biological Testing

Clarifying remarks (for public users):

Hersteller Arzneimittel: Loba Biotech GmbH; Probebetrieb betreffend Verfahren INS-480253-103537375 bis zum: / valid until: 31.03.2026; Hersteller Wirkstoffe: Loba Biotech GmbH; Probebetrieb betreffend Verfahren INS-480253-103537375 bis zum: / valid until: 31.03.2026;

Withdrawal comments in English: Superseded because new certificate was issued following an inspection

Withdrawal comments in National Language: Superseded because new certificate was issued following an inspection

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.