Suppliers / Janssen Ortho

Janssen Ortho

Puerto Rico 4 duplicate records merged Updated 9 July 2026

Janssen Ortho is a finished-dose manufacturer based in Puerto Rico. It appears in 157 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with Health Canada, ARCSA (EC) and NAFDAC (NG). Its GMP standing is certified by ANVISA (Brazil), NAFDAC (NG) and NCELS (KZ). Its most recent recorded inspection, by US FDA, closed on 28 March 2023 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
157
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 28 March 2023 VAI US FDA
  • 28 August 2018 VAI US FDA
  • 26 May 2017 VAI US FDA
  • 29 May 2015 VAI US FDA
  • 22 February 2013 VAI US FDA
  • 13 June 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Gurabo, United Arab Emirates Not on file
Puertoricco, Nigeria Not on file
GURABO, Puerto Rico Not on file
Gurabo, United States 3002942061

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 139 None
ARCSA (EC) 13 None
NAFDAC (NG) 2 1
MINSA (CR) 2 None
SFDA (Saudi Arabia) 1 None
ANVISA (Brazil) None 2
NCELS (KZ) None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 28 March 2023.

Sources on this page

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