Suppliers / Janssen-Cilag Farmaceutica Ltda

Janssen-Cilag Farmaceutica Ltda

Brazil Updated 9 July 2026

Janssen-Cilag Farmaceutica Ltda is an API and finished-dose manufacturer based in Brazil. It holds 5 active US drug master files across a filed portfolio of 3 molecules. Its filings concentrate with ANVISA (Brazil), US FDA and INFARMED (PT). Its GMP standing is certified by US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 7 October 2025 as VAI.

5
active US DMFs
0
valid CEPs
12
registered plants 7 with an FDA FEI number
685
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
7 of 7 confirmed
Inspections
7 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 7 October 2025 VAI US FDA
  • 5 September 2025 VAI US FDA
  • 14 August 2025 NAI US FDA
  • 29 July 2025 VAI US FDA
  • 12 May 2025 VAI US FDA
  • 10 March 2025 NAI US FDA
  • 24 January 2025 VAI US FDA
  • 27 September 2024 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Belgium, Belgium 3002807336
Belgium, Belgium 3002807334
Belgium, Belgium 3002807337
São Paulo, Brazil Not on file
SAO PAULO, Brazil Not on file
SÃO JOSÉ DOS CAMPOS, Brazil Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Methylphenidate US FDA 2
Rivaroxaban US FDA 2
Rilpivirine US FDA 1

Also appears on these molecule pages

Apalutamide finished dose Bendamustine finished dose Bosentan finished dose Canagliflozin finished dose Chlorzoxazone finished dose Cinnarizine finished dose Cladribine finished dose Cobalamin finished dose Cobicistat finished dose Cyclobenzaprine finished dose Dapoxetine finished dose Darunavir finished dose
Show 32 more molecule pages
Decitabine finished dose Econazole finished dose Emtricitabine finished dose Esketamine finished dose Etomidate finished dose Flavoxate finished dose Galantamine finished dose Gemcitabine finished dose Hydromorphone finished dose Itraconazole finished dose Ketoconazole finished dose Ketotifen finished dose Leuprolide finished dose Levocarnitine finished dose Loperamide finished dose Macitentan finished dose Mebendazole finished dose Methylphenidate API Nicotine finished dose Norgestimate finished dose Oxybutynin finished dose Paliperidone finished dose Prucalopride finished dose Rabeprazole finished dose Rilpivirine API Risperidone finished dose Tapentadol finished dose Tenofovir Alafenamide finished dose Thiocolchicoside finished dose Topiramate finished dose Trabectedin finished dose Rivaroxaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
ANVISA (Brazil) 316 5
US FDA 220 7
INFARMED (PT) 122 None
DIGEMAPS (DO) 6 None
ARCSA (EC) 5 None
SFDA (Saudi Arabia) 5 None

Questions about Janssen-Cilag Farmaceutica Ltda

Does Janssen-Cilag Farmaceutica Ltda hold a US DMF or a CEP?
Janssen-Cilag Farmaceutica Ltda holds 5 active US drug master files. 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.
Is Janssen-Cilag Farmaceutica Ltda FDA-registered?
7 sites operated by Janssen-Cilag Farmaceutica Ltda carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Janssen-Cilag Farmaceutica Ltda's last inspection go?
The most recent inspection on record closed on 7 October 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Janssen-Cilag Farmaceutica Ltda manufacture?
12 registered sites are on record, in Belgium, Brazil, Ireland and Italy (Belgium, São Paulo and SAO Paulo among others). Every site is listed on this page with the register it came from.
What does Janssen-Cilag Farmaceutica Ltda make?
3 molecules are on record against Janssen-Cilag Farmaceutica Ltda, including Methylphenidate, Rivaroxaban and Rilpivirine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Janssen-Cilag Farmaceutica Ltda's GMP?
Current GMP certificates are on record from US FDA and ANVISA (Brazil). 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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Open risk flags

  • 5 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 7 October 2025.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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