Suppliers / Janssen Pharmaceutica

Janssen Pharmaceutica

Belgium Updated 9 July 2026

Janssen Pharmaceutica is an API and finished-dose manufacturer based in Belgium. It holds 23 valid CEPs across a filed portfolio of 20 molecules. Its filings concentrate with SFDA (Saudi Arabia), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by ANVISA (Brazil), MFDS (Korea) and NAFDAC (NG).

0
active US DMFs
23
valid CEPs
3
registered plants
84
filings across 7 regulators

Registered plants

Site FDA FEI
Beerse, United Arab Emirates Not on file
BEERSE, Belgium Not on file
Beerse, Belgium Not on file

What they file, and where

Molecule Regulators Docs
Domperidone EDQM 2
Fentanyl EDQM 2
Itraconazole EDQM 2
Loperamide EDQM, SFDA (Saudi Arabia) 2
Methylphenidate EDQM 2
Miconazole EDQM 2
Alfentanil EDQM 1
Cinnarizine EDQM 1
Econazole EDQM 1
Flubendazole EDQM 1
Show all 20 molecules on file
Flunarizine Dihydrochloride EDQM 1
Galantamine Hydrobromide EDQM 1
Haloperidol EDQM 1
Haloperidol Decanoate EDQM 1
Ketoconazole EDQM 1
Levocabastine EDQM 1
Nebivolol SFDA (Saudi Arabia) 1
Risperidone EDQM 1
Sufentanil EDQM 1
Trabectedin SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Canagliflozin finished dose Cinnarizine API Darunavir finished dose Domperidone API Econazole API Esketamine finished dose Fentanyl API Flunarizine API Galantamine finished dose Haloperidol API Haloperidol Decanoate API Ibrutinib finished dose
Show 9 more molecule pages
Itraconazole API Ketoconazole API Loperamide API Methylphenidate API Miconazole API Nebivolol API Paliperidone finished dose Risperidone API Trabectedin API

Filings and GMP by regulator

Regulator Filings GMP certificates
SFDA (Saudi Arabia) 28 None
ARCSA (EC) 22 None
MINSA (CR) 12 None
NAFDAC (NG) 9 1
Health Canada 9 None
MPA (SE) 2 None
ANVISA (Brazil) None 7
MFDS (Korea) None 2

Questions about Janssen Pharmaceutica

Does Janssen Pharmaceutica hold a US DMF or a CEP?
Janssen Pharmaceutica holds 23 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Where does Janssen Pharmaceutica manufacture?
3 registered sites are on record, in United Arab Emirates and Belgium (Beerse and Beerse among others). Every site is listed on this page with the register it came from.
What does Janssen Pharmaceutica make?
20 molecules are on record against Janssen Pharmaceutica, including Domperidone, Fentanyl, Itraconazole and Loperamide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Janssen Pharmaceutica's GMP?
Current GMP certificates are on record from ANVISA (Brazil), MFDS (Korea) and NAFDAC (NG). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates