Sumitomo Pharma
Japan 13 employees Updated 9 July 2026
Sumitomo Pharma is a finished-dose manufacturer based in Japan. It holds one active US drug master file. Its filings concentrate with Health Canada and NMPA (CN). Its GMP standing is certified by US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 7 August 2025 as VAI.
3
registered plants
2 with an FDA FEI number
26
filings
across 2 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
- 7 August 2025 VAI US FDA
- 11 July 2025 VAI US FDA
- 22 November 2019 VAI US FDA
- 16 April 2019 VAI US FDA
- 27 July 2018 NAI US FDA
- 17 February 2017 VAI US FDA
- 9 September 2016 VAI US FDA
- 12 September 2014 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| OITA, Japan | Not on file |
| Japan, Japan | 3003028650 |
| Japan, Japan | 3005619533 |
What they file, and where
| Molecule | Regulators | Docs |
| Zonisamide | US FDA | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| Health Canada | 24 | None |
| NMPA (CN) | 2 | None |
| US FDA | None | 2 |
| ANVISA (Brazil) | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 7 August 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates