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

Questions about Janssen Ortho

Does Janssen Ortho hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Janssen Ortho. It does have 157 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Janssen Ortho FDA-registered?
One site operated by Janssen Ortho carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Janssen Ortho's last inspection go?
The most recent inspection on record closed on 28 March 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Janssen Ortho manufacture?
4 registered sites are on record, in United Arab Emirates, Nigeria, Puerto Rico and United States (Gurabo, Puertoricco and Gurabo among others). Every site is listed on this page with the register it came from.
Which regulators recognise Janssen Ortho's GMP?
Current GMP certificates are on record from ANVISA (Brazil), NAFDAC (NG) and NCELS (KZ). 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

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

Comparable suppliers

Aiac International Pharma also in Puerto Rico Janssen-Cilag Manufacturing also in Puerto Rico Lilly Del Caribe also in Puerto Rico Neolpharma also in Puerto Rico

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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