Suppliers / Janssen Biotech

Janssen Biotech

United States 2 duplicate records merged Updated 9 July 2026

Janssen Biotech is a finished-dose manufacturer based in United States. It appears in 5 regulatory filings across 1 regulator, without an active US DMF or CEP on file.

0
active US DMFs
0
valid CEPs
1
registered plants
5
filings across 1 regulators

Registered plants

Site FDA FEI
MALVERN, United States Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
SFDA (Saudi Arabia) 5 None

Questions about Janssen Biotech

Does Janssen Biotech hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Janssen Biotech. It does have 5 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Janssen Biotech manufacture?
1 registered site is on record, in United States (Malvern). Every site is listed on this page with the register it came from.
Where does Janssen Biotech file?
Filings are on record with SFDA (Saudi Arabia), 5 in total.

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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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