Sumitomo Chemical
Japan SMM.MU Updated 9 July 2026
Sumitomo Chemical is an API manufacturer based in Japan. It holds 2 active US drug master files 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 31 October 2025 as VAI.
3
registered plants
3 with an FDA FEI number
1
filings
across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 31 October 2025 VAI US FDA
- 2 November 2023 NAI US FDA
- 6 September 2019 VAI US FDA
- 8 February 2019 NAI US FDA
- 8 December 2017 VAI US FDA
- 23 September 2016 VAI US FDA
- 15 July 2016 VAI US FDA
- 22 April 2016 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Japan, Japan | 3002808125 |
| Japan, Japan | 3002808279 |
| Japan, Japan | 3003973514 |
What they file, and where
| Molecule | Regulators | Docs |
| Disopyramide | US FDA | 1 |
| Hydralazine | US FDA | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| BRELA (TZ) | 1 | None |
| US FDA | None | 2 |
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Open risk flags
- 6 active litigation matters are on record.
- The most recent inspection outcome was VAI, on 31 October 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates