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.
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
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
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 VAI, on 21 November 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates