Suppliers / Ajinomoto Health and Nutrition North America

Ajinomoto Health and Nutrition North America

United States 2 duplicate records merged Updated 9 July 2026

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

Ajinomoto Health and Nutrition North America is an API manufacturer based in United States. It holds 12 active US drug master files across a filed portfolio of 10 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 12 September 2025 as VAI.

12
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 12 September 2025 VAI US FDA
  • 6 August 2025 NAI US FDA
  • 14 November 2023 OAI US FDA
  • 8 December 2017 VAI US FDA
  • 21 May 2014 VAI US FDA
  • 13 April 2010 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Raleigh, United States 1033510
Eddyville, United States 3003918018

What they file, and where

Molecule Regulators Docs
Histidine US FDA 2
Serine US FDA 2
Alanine US FDA 1
Amino Acids US FDA 1
Leucine US FDA 1
Lysine US FDA 1
Proline US FDA 1
Threonine US FDA 1
Tryptophan US FDA 1
Valine US FDA 1

Also appears on these molecule pages

Alanine API Histidine API Leucine API Lysine API Proline API Serine API Threonine API Valine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 2

Questions about Ajinomoto Health and Nutrition North America

Does Ajinomoto Health and Nutrition North America hold a US DMF or a CEP?
Ajinomoto Health and Nutrition North America holds 12 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Ajinomoto Health and Nutrition North America FDA-registered?
2 sites operated by Ajinomoto Health and Nutrition North America carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Ajinomoto Health and Nutrition North America's last inspection go?
The most recent inspection on record closed on 12 September 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file, of which 1 closed as OAI.
Where does Ajinomoto Health and Nutrition North America manufacture?
2 registered sites are on record, in United States (Raleigh and Eddyville). Every site is listed on this page with the register it came from.
What does Ajinomoto Health and Nutrition North America make?
10 molecules are on record against Ajinomoto Health and Nutrition North America, including Histidine, Serine, Alanine and Amino Acids. Each links through to that molecule's full manufacturer list.
Which regulators recognise Ajinomoto Health and Nutrition North America's GMP?
Current GMP certificates are on record from US FDA. 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

  • The most recent inspection outcome was VAI, on 12 September 2025.

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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