Spera Nexus
Japan Updated 9 July 2026
Spera Nexus is an API manufacturer based in Japan. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 10 July 2025 as NAI.
1
registered plants
1 with an FDA FEI number
0
filings
across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 10 July 2025 NAI US FDA
- 1 November 2019 NAI US FDA
- 16 January 2015 VAI US FDA
- 19 April 2012 NAI 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 | 3002807324 |
What they file, and where
| Molecule | Regulators | Docs |
| Phenylephrine | US FDA | 1 |
| Pilocarpine | US FDA | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was NAI, on 10 July 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates