Suppliers / Sumitomo Pharma

Sumitomo Pharma

Japan 13 employees Updated 9 July 2026

Sumitomo Pharma is an API and 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.

1
active US DMFs
0
valid CEPs
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
Plants
2 of 2 confirmed
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

Eslicarbazepine finished dose Estradiol finished dose Eszopiclone finished dose Norethisterone finished dose Relugolix finished dose Zonisamide API

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

Questions about Sumitomo Pharma

Does Sumitomo Pharma hold a US DMF or a CEP?
Sumitomo Pharma holds 1 active US drug master file. 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 Sumitomo Pharma FDA-registered?
2 sites operated by Sumitomo Pharma carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Sumitomo Pharma's last inspection go?
The most recent inspection on record closed on 7 August 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Sumitomo Pharma manufacture?
3 registered sites are on record, in Japan (Oita and Japan among others). Every site is listed on this page with the register it came from.
What does Sumitomo Pharma make?
1 molecule is on record against Sumitomo Pharma, including Zonisamide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sumitomo Pharma's GMP?
Current GMP certificates are on record from US FDA and ANVISA (Brazil). 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 7 August 2025.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates