Suppliers / Asahi Kasei Finechem

Asahi Kasei Finechem

Japan Updated 9 July 2026

Asahi Kasei Finechem is an API manufacturer based in Japan. It holds one active US drug master file and 2 valid CEPs across a filed portfolio of 2 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 14 November 2025 as VAI.

1
active US DMFs
2
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
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 November 2025 VAI US FDA
  • 29 June 2018 NAI US FDA
  • 12 June 2015 VAI US FDA

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

Registered plants

Site FDA FEI
Osaka, Japan Not on file
Japan, Japan 3002806404

What they file, and where

Molecule Regulators Docs
Cytarabine EDQM, SFDA (Saudi Arabia), US FDA 3
Tranexamic Acid EDQM 1

Also appears on these molecule pages

Cytarabine API Tranexamic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Asahi Kasei Finechem

Does Asahi Kasei Finechem hold a US DMF or a CEP?
Asahi Kasei Finechem holds 1 active US drug master file and 2 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 Asahi Kasei Finechem FDA-registered?
One site operated by Asahi Kasei Finechem 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 Asahi Kasei Finechem's last inspection go?
The most recent inspection on record closed on 14 November 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Asahi Kasei Finechem manufacture?
2 registered sites are on record, in Japan (Osaka and Japan). Every site is listed on this page with the register it came from.
What does Asahi Kasei Finechem make?
2 molecules are on record against Asahi Kasei Finechem, including Cytarabine and Tranexamic Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise Asahi Kasei Finechem'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 VAI, on 14 November 2025.

Comparable suppliers

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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