Suppliers / Shanghai Ajinomoto Amino Acid

Shanghai Ajinomoto Amino Acid

China Updated 9 July 2026

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

Shanghai Ajinomoto Amino Acid is an API manufacturer based in China. It holds 7 active US drug master files across a filed portfolio of 7 molecules. Its GMP standing is certified by MFDS (Korea), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 10 May 2024 as VAI.

7
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 10 May 2024 VAI US FDA
  • 29 September 2016 NAI US FDA

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

Registered plants

Site FDA FEI
Shanghai, China Not on file
China, China 3004567034

What they file, and where

Molecule Regulators Docs
Phenylalanine SFDA (Saudi Arabia), US FDA 2
Alanine US FDA 1
Isoleucine US FDA 1
Leucine US FDA 1
Lysine US FDA 1
Threonine US FDA 1
Valine US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2
US FDA None 1
EMA None 1

Questions about Shanghai Ajinomoto Amino Acid

Does Shanghai Ajinomoto Amino Acid hold a US DMF or a CEP?
Shanghai Ajinomoto Amino Acid holds 7 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 Shanghai Ajinomoto Amino Acid FDA-registered?
One site operated by Shanghai Ajinomoto Amino Acid carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Shanghai Ajinomoto Amino Acid's last inspection go?
The most recent inspection on record closed on 10 May 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Shanghai Ajinomoto Amino Acid manufacture?
2 registered sites are on record, in China (Shanghai and China). Every site is listed on this page with the register it came from.
What does Shanghai Ajinomoto Amino Acid make?
7 molecules are on record against Shanghai Ajinomoto Amino Acid, including Phenylalanine, Alanine, Isoleucine and Leucine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shanghai Ajinomoto Amino Acid's GMP?
Current GMP certificates are on record from MFDS (Korea), US FDA and EMA. 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.

Comparing suppliers?

Choose your molecules and target markets. Shanghai Ajinomoto Amino Acid comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 10 May 2024.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates