Suppliers / Bushu Pharmaceuticals

Bushu Pharmaceuticals

Japan 44 employees Updated 9 July 2026

Bushu Pharmaceuticals is a finished-dose manufacturer based in Japan. It appears in 32 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), EDE (AE) and ARCSA (EC). Its GMP standing is certified by ANVISA (Brazil), NAFDAC (NG) and US FDA. Its most recent recorded inspection, by US FDA, closed on 10 November 2023 as NAI.

0
active US DMFs
0
valid CEPs
4
registered plants 2 with an FDA FEI number
32
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 10 November 2023 NAI US FDA
  • 2 December 2022 VAI US FDA
  • 30 August 2019 NAI US FDA
  • 2 February 2017 VAI US FDA
  • 16 September 2016 VAI US FDA
  • 25 October 2013 VAI US FDA
  • 15 July 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Saitama-ken, United Arab Emirates Not on file
SAITAMA, Japan Not on file
Japan, Japan 3011071488
Japan, Japan 3005709762

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 19 None
EDE (AE) 4 None
ARCSA (EC) 4 None
DIGEMAPS (DO) 3 None
NAFDAC (NG) 1 1
BRELA (TZ) 1 None
ANVISA (Brazil) None 2
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was NAI, on 10 November 2023.

Sources on this page

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