Suppliers / Sekisui Medical

Sekisui Medical

Japan 35 employees Updated 9 July 2026

Sekisui Medical is an API manufacturer based in Japan. It holds 4 active US drug master files and 3 valid CEPs across a filed portfolio of 4 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 21 November 2025 as VAI.

4
active US DMFs
3
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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 21 November 2025 VAI US FDA
  • 8 March 2019 NAI US FDA
  • 27 July 2017 NAI US FDA
  • 17 June 2016 OAI US FDA
  • 27 October 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Tokyo, Japan Not on file
Japan, Japan 3002806840

What they file, and where

Molecule Regulators Docs
Methionine EDQM, SFDA (Saudi Arabia), US FDA 3
Clemastine EDQM, US FDA 2
N-Acetyltyrosine EDQM, US FDA 2
Taurine SFDA (Saudi Arabia), US FDA 2

Also appears on these molecule pages

Methionine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Sekisui Medical

Does Sekisui Medical hold a US DMF or a CEP?
Sekisui Medical holds 4 active US drug master files and 3 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 Sekisui Medical FDA-registered?
One site operated by Sekisui Medical 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 Sekisui Medical's last inspection go?
The most recent inspection on record closed on 21 November 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file, of which 1 closed as OAI.
Where does Sekisui Medical manufacture?
2 registered sites are on record, in Japan (Tokyo and Japan). Every site is listed on this page with the register it came from.
What does Sekisui Medical make?
4 molecules are on record against Sekisui Medical, including Methionine, Clemastine, N-Acetyltyrosine and Taurine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sekisui Medical'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 21 November 2025.

Comparable suppliers

Amino Chemicals shares 1 molecule Sthree Chemicals shares 1 molecule Evonik Rexim (Nanning) Pharmaceutical shares 1 molecule Shijiazhuang Jirong Pharmaceutical shares 1 molecule

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