Suppliers / Sumitomo Chemical

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.

2
active US DMFs
0
valid CEPs
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
Plants
3 of 3 confirmed
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

Hydralazine API

Filings and GMP by regulator

Regulator Filings GMP certificates
BRELA (TZ) 1 None
US FDA None 2

Questions about Sumitomo Chemical

Does Sumitomo Chemical hold a US DMF or a CEP?
Sumitomo Chemical holds 2 active US drug master files. 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 Chemical FDA-registered?
3 sites operated by Sumitomo Chemical 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 Chemical's last inspection go?
The most recent inspection on record closed on 31 October 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Sumitomo Chemical manufacture?
3 registered sites are on record, in Japan (Japan among others). Every site is listed on this page with the register it came from.
What does Sumitomo Chemical make?
2 molecules are on record against Sumitomo Chemical, including Disopyramide and Hydralazine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sumitomo Chemical'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

  • 6 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 31 October 2025.

Comparable suppliers

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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