Suppliers / Sato Pharmaceutical

Sato Pharmaceutical

Japan 111 employees Updated 9 July 2026

Sato Pharmaceutical is a finished-dose manufacturer based in Japan. It appears in 48 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with DH (HK) and HSA (SG). Its GMP standing is certified by HSA (SG). Its most recent recorded inspection, by US FDA, closed on 21 November 2025 as OAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
48
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 21 November 2025 OAI US FDA
  • 25 October 2019 VAI US FDA
  • 3 July 2018 VAI US FDA
  • 12 February 2016 OAI 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 3004055563

Filings and GMP by regulator

Regulator Filings GMP certificates
DH (HK) 37 None
HSA (SG) 11 4

Questions about Sato Pharmaceutical

Does Sato Pharmaceutical hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Sato Pharmaceutical. It does have 48 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Sato Pharmaceutical FDA-registered?
One site operated by Sato Pharmaceutical carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Sato Pharmaceutical's last inspection go?
The most recent inspection on record closed on 21 November 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 4 inspections are on file, of which 2 closed as OAI.
Where does Sato Pharmaceutical manufacture?
1 registered site is on record, in Japan (Japan). Every site is listed on this page with the register it came from.
Which regulators recognise Sato Pharmaceutical's GMP?
Current GMP certificates are on record from HSA (SG). 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 OAI, on 21 November 2025.

Comparable suppliers

Bushu Pharmaceuticals also in Japan Chugai Pharma Manufacturing also in Japan Eisai also in Japan Hisamitsu Pharmaceutical also in Japan Kyowa Kirin 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