Suppliers / Shanghai Plumino Amino Acid

Shanghai Plumino Amino Acid

China Updated 9 July 2026

Shanghai Plumino Amino Acid is an API manufacturer based in China. It holds one active US drug master file and 14 valid CEPs across a filed portfolio of 13 molecules. Its GMP standing is certified by MFDS (Korea), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 15 December 2023 as VAI.

1
active US DMFs
14
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

  • 15 December 2023 VAI US FDA
  • 9 August 2019 VAI 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 3005253125

What they file, and where

Molecule Regulators Docs
Arginine EDQM 2
Histidine EDQM 2
Alanine EDQM 1
Amino Acids US FDA 1
Aspartic Acid EDQM 1
Isoleucine EDQM 1
Leucine EDQM 1
Lysine EDQM 1
Phenylalanine EDQM 1
Proline EDQM 1
Show all 13 molecules on file
Serine EDQM 1
Threonine EDQM 1
Valine EDQM 1

Also appears on these molecule pages

Alanine API Arginine API Aspartic Acid API Histidine API Isoleucine API Leucine API Lysine API Phenylalanine API Proline API Serine API Threonine API Valine API

Filings and GMP by regulator

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

Questions about Shanghai Plumino Amino Acid

Does Shanghai Plumino Amino Acid hold a US DMF or a CEP?
Shanghai Plumino Amino Acid holds 1 active US drug master file and 14 valid CEPs. 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 Plumino Amino Acid FDA-registered?
One site operated by Shanghai Plumino 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 Plumino Amino Acid's last inspection go?
The most recent inspection on record closed on 15 December 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Shanghai Plumino 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 Plumino Amino Acid make?
13 molecules are on record against Shanghai Plumino Amino Acid, including Arginine, Histidine, Alanine and Amino Acids. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shanghai Plumino Amino Acid's GMP?
Current GMP certificates are on record from MFDS (Korea), EMA and 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 15 December 2023.

Comparable suppliers

Ajinomoto shares 12 molecules Amino Chemicals shares 12 molecules Kyowa Hakko Bio shares 12 molecules Mianyang Shengshi Health Technology shares 4 molecules Evonik Rexim (Nanning) Pharmaceutical shares 4 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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