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The Certificate has been withdrawn, withdrawn date is : 2026-05-26

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Federal Agency For Medicines And Health Products

CERTIFICATE NUMBER: BE/GMP/2023/058

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 Belgium confirms the following:

The manufacturer: Janssen Pharmaceutica

Site address:

Turnhoutseweg 30, Beerse, 2340, Belgium

OMS Organisation Id. / OMS Location Id.: ORG-100000625 / LOC-100005958

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. 2 H in accordance with Art. 40 of Directive 2001/83/EC, transposed in the following national legislation:Article 12 bis, § 1 of the Law of 25th March 1964 related to the Medicinal Products for Human Use.

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 2023-03-31 , 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.

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

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

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.4  Small volume liquids
           1.1.1.6  Other: Sterilization of API's(en)
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.3  Small volume liquids
   1.1.3  Batch certification

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.5  Liquids for external use
           1.2.1.6  Liquids for internal use
           1.2.1.11  Semi-solids
           1.2.1.14  Transdermal patches
   1.2.2  Batch certification

1.3 Biological medicinal products (list of product types)

1.3.2 Batch Certification (list of product types)
1.3.2.2 Immunological products

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.5  Liquids for external use
           1.5.1.6  Liquids for internal use
           1.5.1.11  Semi-solids
           1.5.1.14  Transdermal patches
   1.5.2  Secondary packaging

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

   2.1.1  Microbiological: sterility
   2.1.2  Microbiological: non-sterility
   2.1.3  Chemical/Physical
   2.1.4  Biological

2.2 Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.1  Aseptically prepared
   2.2.2  Non-sterile products
   2.2.3  Biological medicinal products
           2.2.3.2  Immunological products

2.3 Other importation activities

2.3.1 Site of physical importation
2.3.2 Importation of intermediate which undergoes further processing

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

[154229-18-2]ABIRATERONE ACETATE(en)

[84553386-0]BEDAQUILINE FUMARATE(en)

[16699-20-0]CINNARIZINE(en)

[635728-49-3]DARUNAVIR ETHANOLATE(en)

[57808-66-9]DOMPERIDONE(en)

[83898-65-1]DOMPERIDONE MALEATE(en)

[33125-97-2]ETOMIDATE(en)

[269055-15-4]ETRAVIRINE(en)

[437-38-7]FENTANYL(en)

[1953-04-4]GALANTAMINE HYDROBROMIDE(en)

[52-86-8]HALOPERIDOL(en)

[74050-97-8]HALOPERIDOL DECANOATE(en)

[84625-61-6]ITRACONAZOLE(en)

[74050-98-9]KETANSERIN(en)

[65277-42-1]KETOCONAZOLE(en)

[79547-78-7]LEVOCABASTINE HYDROCHLORIDE(en)

[34552-83-5]LOPERAMIDE HYDROCHLORIDE(en)

[22916-47-8]MICONAZOLE(en)

[22832-87-7]MICONAZOLE NITRATE(en)

[199739-10-1]PALIPERIDONE PALMITATE(en)

[179474-85-2]PRUCALOPRIDE SUCCINATE(en)

[700361-47-3]RILPIVIRINE HYDROCHLORIDE(en)

CANAGLIFLOZIN(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:ABIRATERONE ACETATE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:BEDAQUILINE FUMARATE

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:CINNARIZINE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:DARUNAVIR ETHANOLATE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:DOMPERIDONE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:DOMPERIDONE MALEATE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:ETOMIDATE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:ETRAVIRINE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:FENTANYL

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:GALANTAMINE HYDROBROMIDE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:HALOPERIDOL

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:HALOPERIDOL DECANOATE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:ITRACONAZOLE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:KETANSERIN

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:KETOCONAZOLE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:LEVOCABASTINE HYDROCHLORIDE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:LOPERAMIDE HYDROCHLORIDE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:MICONAZOLE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:MICONAZOLE NITRATE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:PALIPERIDONE PALMITATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Dissolve crude API, filtering and crystalize as base or as salt

3.4 Manufacture of sterile Active Substance

3.4.1  Aseptically prepared

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

3.6.3  Microbiological testing including sterility testing

Active Substance:PRUCALOPRIDE SUCCINATE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:RILPIVIRINE HYDROCHLORIDE

3.6 Quality Control Testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:CANAGLIFLOZIN

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Withdrawal comments in English: new certificate available BE/GMP/2026/026-026

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