Suppliers / Kyowa Pharma Chemical

Kyowa Pharma Chemical

Japan 13 employees Updated 9 July 2026

Kyowa Pharma Chemical is an API manufacturer based in Japan. It holds 5 active US drug master files and 4 valid CEPs across a filed portfolio of 5 molecules. Its most recent recorded inspection, by US FDA, closed on 9 December 2022 as VAI.

5
active US DMFs
4
valid CEPs
2
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 9 December 2022 VAI US FDA
  • 20 January 2017 VAI US FDA
  • 28 August 2014 NAI US FDA
  • 3 March 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Takaoka, Japan Not on file
Japan, Japan 3003128853

What they file, and where

Molecule Regulators Docs
Dinoprostone EDQM, US FDA 4
Latanoprost EDQM, US FDA 2
Tranexamic Acid EDQM, SFDA (Saudi Arabia) 2
Bimatoprost US FDA 1
Olopatadine US FDA 1

Also appears on these molecule pages

Latanoprost API Olopatadine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None

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Open risk flags

  • The most recent inspection outcome was VAI, on 9 December 2022.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability