Suppliers / Kyowa Hakko Bio

Kyowa Hakko Bio

Japan Updated 9 July 2026

Kyowa Hakko Bio is an API manufacturer based in Japan. It holds 2 active US drug master files and 16 valid CEPs across a filed portfolio of 17 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 20 September 2024 as NAI.

2
active US DMFs
16
valid CEPs
3
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
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 20 September 2024 NAI US FDA
  • 15 April 2022 OAI US FDA
  • 8 November 2019 OAI US FDA
  • 8 September 2017 OAI US FDA
  • 20 March 2014 NAI US FDA
  • 27 October 2011 VAI US FDA
  • 25 June 2010 OAI US FDA

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

Registered plants

Site FDA FEI
MILANO, Italy Not on file
Tokyo, Japan Not on file
Japan, Japan 3002807424

What they file, and where

Molecule Regulators Docs
Lysine EDQM, SFDA (Saudi Arabia) 3
Amino Acids US FDA 2
Arginine EDQM 2
Histidine EDQM 2
Proline EDQM, SFDA (Saudi Arabia) 2
Serine EDQM, SFDA (Saudi Arabia) 2
Threonine EDQM, SFDA (Saudi Arabia) 2
Tryptophan EDQM, SFDA (Saudi Arabia) 2
Valine EDQM, SFDA (Saudi Arabia) 2
Alanine EDQM 1
Show all 17 molecules on file
Aspartic Acid SFDA (Saudi Arabia) 1
Glutathione EDQM 1
Isoleucine EDQM 1
L-Ornithine Monohydrochloride SFDA (Saudi Arabia) 1
Leucine EDQM 1
Phenylalanine EDQM 1
Taurine SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Alanine API Arginine API Aspartic Acid API Glutathione API Histidine API Isoleucine API Leucine API Lysine API Phenylalanine API Proline API Serine API Threonine API
Show 1 more molecule pages
Valine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Kyowa Hakko Bio

Does Kyowa Hakko Bio hold a US DMF or a CEP?
Kyowa Hakko Bio holds 2 active US drug master files and 16 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 Kyowa Hakko Bio FDA-registered?
One site operated by Kyowa Hakko Bio 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 Kyowa Hakko Bio's last inspection go?
The most recent inspection on record closed on 20 September 2024 as NAI (No Action Indicated: nothing objectionable was found). 7 inspections are on file, of which 4 closed as OAI.
Where does Kyowa Hakko Bio manufacture?
3 registered sites are on record, in Italy and Japan (Milano, Tokyo and Japan). Every site is listed on this page with the register it came from.
What does Kyowa Hakko Bio make?
17 molecules are on record against Kyowa Hakko Bio, including Lysine, Amino Acids, Arginine and Histidine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Kyowa Hakko Bio'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 NAI, on 20 September 2024.

Comparable suppliers

Ajinomoto shares 12 molecules Amino Chemicals shares 12 molecules Shanghai Plumino Amino Acid 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