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

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

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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