Suppliers / Spera Nexus

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.

2
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
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

Phenylephrine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Spera Nexus

Does Spera Nexus hold a US DMF or a CEP?
Spera Nexus holds 2 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 Spera Nexus FDA-registered?
One site operated by Spera Nexus carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Spera Nexus's last inspection go?
The most recent inspection on record closed on 10 July 2025 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does Spera Nexus manufacture?
1 registered site is on record, in Japan (Japan). Every site is listed on this page with the register it came from.
What does Spera Nexus make?
2 molecules are on record against Spera Nexus, including Phenylephrine and Pilocarpine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Spera Nexus'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 NAI, on 10 July 2025.

Comparable suppliers

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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