Suppliers / Janssen-Cilag Manufacturing

Janssen-Cilag Manufacturing

Puerto Rico 2 duplicate records merged Updated 9 July 2026

Janssen-Cilag Manufacturing is a finished-dose manufacturer based in Puerto Rico. It appears in 36 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), ARCSA (EC) and NPRA (MY). Its GMP standing is certified by NAFDAC (NG), ANVISA (Brazil) and NCELS (KZ).

0
active US DMFs
0
valid CEPs
3
registered plants
36
filings across 6 regulators

Registered plants

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

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 13 None
ARCSA (EC) 8 None
NPRA (MY) 6 None
INVIMA (CO) 5 None
NAFDAC (NG) 2 1
EDE (AE) 2 None
ANVISA (Brazil) None 1
NCELS (KZ) None 1

Questions about Janssen-Cilag Manufacturing

Does Janssen-Cilag Manufacturing hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Janssen-Cilag Manufacturing. It does have 36 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Janssen-Cilag Manufacturing manufacture?
3 registered sites are on record, in United Arab Emirates, Nigeria and Puerto Rico (Gurabo, Puerto Rico and Gurabo). Every site is listed on this page with the register it came from.
Which regulators recognise Janssen-Cilag Manufacturing's GMP?
Current GMP certificates are on record from NAFDAC (NG), ANVISA (Brazil) 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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Sources on this page

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