Suppliers / n.v. Ajinomoto Omnichem

n.v. Ajinomoto Omnichem

Belgium Updated 9 July 2026

The public registers hold a second record for n.v. Ajinomoto Omnichem. The fuller profile, with 34 active US DMFs and 33 valid CEPs, is at Ajinomoto. Figures on this page cover only this record.

n.v. Ajinomoto Omnichem is an API and finished-dose manufacturer based in Belgium. It appears in 1,212 regulatory filings across 23 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), INFARMED (PT) and FAMHP (BE). Its GMP standing is certified by TMDA (TZ), NAFDAC (NG) and INVIMA (CO), among 4 authorities.

0
active US DMFs
0
valid CEPs
3
registered plants
1,212
filings across 23 regulators

Registered plants

Site FDA FEI
Wetteren, Belgium Not on file
Brasil, Colombia Not on file
Montijo, Portugal Not on file

What they file, and where

Molecule Regulators Docs
Gefitinib SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Acalabrutinib finished dose Gefitinib API Olaparib finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 236 None
INFARMED (PT) 185 None
FAMHP (BE) 184 None
INHRR (VE) 181 None
DMP (NO) 63 None
MINSA (CR) 54 None
TMDA (TZ) None 6
NAFDAC (NG) None 2
INVIMA (CO) None 1
NCELS (KZ) None 1

Questions about n.v. Ajinomoto Omnichem

Does n.v. Ajinomoto Omnichem hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for n.v. Ajinomoto Omnichem. It does have 1,212 filings with 23 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does n.v. Ajinomoto Omnichem manufacture?
3 registered sites are on record, in Belgium, Colombia and Portugal (Wetteren, Brasil and Montijo). Every site is listed on this page with the register it came from.
What does n.v. Ajinomoto Omnichem make?
1 molecule is on record against n.v. Ajinomoto Omnichem, including Gefitinib. Each links through to that molecule's full manufacturer list.
Which regulators recognise n.v. Ajinomoto Omnichem's GMP?
Current GMP certificates are on record from TMDA (TZ), NAFDAC (NG), INVIMA (CO) 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