Suppliers / Organon Usa

Organon Usa

United States OGN Updated 9 July 2026

Organon Usa is a finished-dose manufacturer based in United States. It appears in 1,650 regulatory filings across 37 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), FAMHP (BE) and INFARMED (PT). Its GMP standing is certified by HSA (SG), NAFDAC (NG) and EAEU_EEC.

0
active US DMFs
0
valid CEPs
7
registered plants
1,650
filings across 37 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Oss, United Arab Emirates Not on file
OSS, United Arab Emirates Not on file
Luzern, Switzerland Not on file
The Netherlands, Nigeria Not on file
LA VICTORIA, Peru Not on file
Terrugem, Portugal Not on file

1 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 242 None
FAMHP (BE) 196 None
INFARMED (PT) 146 None
SWISSMEDIC (CH) 122 None
MPA (SE) 118 None
EMA 118 None
HSA (SG) None 2
NAFDAC (NG) None 1
EAEU_EEC None 1

Scale

Year Revenue Exports Destinations
2025 $6.2B Not reported Not reported
2024 $6.4B Not reported Not reported
2023 $6.3B Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Organon Usa

Does Organon Usa hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Organon Usa. It does have 1,650 filings with 37 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Organon Usa manufacture?
7 registered sites are on record, in United Arab Emirates, Switzerland, Nigeria and Peru (Oss, OSS and Luzern among others). Every site is listed on this page with the register it came from.
Which regulators recognise Organon Usa's GMP?
Current GMP certificates are on record from HSA (SG), NAFDAC (NG) and EEC (Eurasian Economic Union). 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

  • 32 active litigation matters are on record.

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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
Company filings
Revenue as reported