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

Bimatoprost API Latanoprost API Olopatadine API Tranexamic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None

Questions about Kyowa Pharma Chemical

Does Kyowa Pharma Chemical hold a US DMF or a CEP?
Kyowa Pharma Chemical holds 5 active US drug master files and 4 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 Pharma Chemical FDA-registered?
One site operated by Kyowa Pharma Chemical 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 Pharma Chemical's last inspection go?
The most recent inspection on record closed on 9 December 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Kyowa Pharma Chemical manufacture?
2 registered sites are on record, in Japan (Takaoka and Japan). Every site is listed on this page with the register it came from.
What does Kyowa Pharma Chemical make?
5 molecules are on record against Kyowa Pharma Chemical, including Dinoprostone, Latanoprost, Tranexamic Acid and Bimatoprost. Each links through to that molecule's full manufacturer list.
Where does Kyowa Pharma Chemical file?
Filings are on record with MINSA (CR), 1 in total.

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 9 December 2022.

Comparable suppliers

MSN Laboratories shares 3 molecules FDC Limited shares 3 molecules Industriale Chimica shares 2 molecules Newchem shares 2 molecules Everlight Chemical Industrial shares 2 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