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

Questions about Bushu Pharmaceuticals

Does Bushu Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Bushu Pharmaceuticals. It does have 32 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Bushu Pharmaceuticals FDA-registered?
2 sites operated by Bushu Pharmaceuticals 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 Bushu Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 10 November 2023 as NAI (No Action Indicated: nothing objectionable was found). 7 inspections are on file.
Where does Bushu Pharmaceuticals manufacture?
4 registered sites are on record, in United Arab Emirates and Japan (Saitama-ken, Saitama and Japan among others). Every site is listed on this page with the register it came from.
Which regulators recognise Bushu Pharmaceuticals's GMP?
Current GMP certificates are on record from ANVISA (Brazil), NAFDAC (NG) and 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.

Comparing suppliers?

Choose your molecules and target markets. Bushu Pharmaceuticals comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

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

Comparable suppliers

Chugai Pharma Manufacturing also in Japan Eisai also in Japan Hisamitsu Pharmaceutical 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