MicroBiopharm Japan
Japan Updated 9 July 2026
MicroBiopharm Japan is a contract 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.
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
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 | 3002807562 |
| Japan, Japan | 3003992082 |
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
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | None | 2 |
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Open risk flags
- The most recent inspection outcome was VAI, on 13 February 2026.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates