Suppliers / N.V. Organon;

N.V. Organon;

Netherlands Updated 9 July 2026

N.V. Organon; is an API and finished-dose manufacturer based in Netherlands. It appears in 407 regulatory filings across 12 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), MPA (SE) and EMA. Its GMP standing is certified by NAFDAC (NG).

0
active US DMFs
0
valid CEPs
3
registered plants
407
filings across 12 regulators

Registered plants

Site FDA FEI
OSS, United Arab Emirates Not on file
The Netherlands, Nigeria Not on file
LA VICTORIA, Peru Not on file

What they file, and where

Molecule Regulators Docs
Rocuronium SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Asenapine finished dose Etonogestrel finished dose Felbamate finished dose Ganirelix finished dose Rocuronium API

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 185 None
MPA (SE) 96 None
EMA 42 None
INFARMED (PT) 36 None
SFDA (Saudi Arabia) 16 None
NMPA (CN) 13 None
NAFDAC (NG) None 1

Questions about N.V. Organon;

Does N.V. Organon; hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for N.V. Organon;. It does have 407 filings with 12 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does N.V. Organon; manufacture?
3 registered sites are on record, in United Arab Emirates, Nigeria and Peru (OSS, The Netherlands and LA Victoria). Every site is listed on this page with the register it came from.
What does N.V. Organon; make?
1 molecule is on record against N.V. Organon;, including Rocuronium. Each links through to that molecule's full manufacturer list.
Which regulators recognise N.V. Organon;'s GMP?
Current GMP certificates are on record from NAFDAC (NG). 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