Suppliers / MicroBiopharm Japan

MicroBiopharm Japan

Japan Updated 9 July 2026

MicroBiopharm Japan is an API manufacturer based in Japan. It holds 4 active US drug master files across a filed portfolio of 4 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 13 February 2026 as VAI.

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

  • 13 February 2026 VAI US FDA
  • 26 January 2024 VAI US FDA
  • 13 September 2019 VAI US FDA
  • 16 March 2018 VAI US FDA
  • 22 September 2017 VAI US FDA
  • 17 June 2016 VAI US FDA
  • 26 September 2014 VAI US FDA
  • 21 December 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
Japan, Japan 3003992082
Japan, Japan 3002807562

What they file, and where

Molecule Regulators Docs
Doxorubicin SFDA (Saudi Arabia), US FDA 2
Calcitriol US FDA 1
Daunorubicin US FDA 1
Epirubicin US FDA 1

Also appears on these molecule pages

Calci contract manufacturing Calcitriol contract manufacturing Daunorubicin contract manufacturing Doxorubicin API Epirubicin API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 2

Questions about MicroBiopharm Japan

Does MicroBiopharm Japan hold a US DMF or a CEP?
MicroBiopharm Japan holds 4 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 MicroBiopharm Japan FDA-registered?
2 sites operated by MicroBiopharm Japan 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 MicroBiopharm Japan's last inspection go?
The most recent inspection on record closed on 13 February 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does MicroBiopharm Japan manufacture?
2 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 MicroBiopharm Japan make?
4 molecules are on record against MicroBiopharm Japan, including Doxorubicin, Calcitriol, Daunorubicin and Epirubicin. Each links through to that molecule's full manufacturer list.
Which regulators recognise MicroBiopharm Japan'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

  • The most recent inspection outcome was VAI, on 13 February 2026.

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Sources on this page

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