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

Lysine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was NAI, on 20 September 2024.

Sources on this page

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