Suppliers / Hisamitsu Pharmaceutical

Hisamitsu Pharmaceutical

Japan 521 employees Updated 9 July 2026

Hisamitsu Pharmaceutical is a finished-dose manufacturer based in Japan. It appears in 14 regulatory filings across 4 regulators, without an active US DMF or CEP on file. Its filings concentrate with DH (HK), HSA (SG) and NPRA (MY). Its GMP standing is certified by HSA (SG), US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 11 July 2025 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 2 with an FDA FEI number
14
filings across 4 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

  • 11 July 2025 VAI US FDA
  • 4 July 2025 VAI US FDA
  • 11 October 2019 VAI US FDA
  • 31 May 2019 VAI US FDA
  • 15 September 2017 VAI US FDA
  • 20 January 2017 VAI US FDA
  • 11 April 2014 VAI US FDA
  • 17 February 2012 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Tosu, United Arab Emirates Not on file
TOSU-SHI, Japan Not on file
Japan, Japan 1000266995
Japan, Japan 3008742780

Filings and GMP by regulator

Regulator Filings GMP certificates
DH (HK) 9 None
HSA (SG) 2 2
NPRA (MY) 2 None
MINSA (CR) 1 None
US FDA None 2
ANVISA (Brazil) None 1

Questions about Hisamitsu Pharmaceutical

Does Hisamitsu Pharmaceutical hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Hisamitsu Pharmaceutical. It does have 14 filings with 4 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Hisamitsu Pharmaceutical FDA-registered?
2 sites operated by Hisamitsu Pharmaceutical 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 Hisamitsu Pharmaceutical's last inspection go?
The most recent inspection on record closed on 11 July 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Hisamitsu Pharmaceutical manufacture?
4 registered sites are on record, in United Arab Emirates and Japan (Tosu, Tosu-shi and Japan among others). Every site is listed on this page with the register it came from.
Which regulators recognise Hisamitsu Pharmaceutical's GMP?
Current GMP certificates are on record from HSA (SG), 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 11 July 2025.

Comparable suppliers

Bushu Pharmaceuticals also in Japan Chugai Pharma Manufacturing also in Japan Eisai also in Japan Kyowa Kirin also in Japan Lead Chemical also in Japan

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