Suppliers / Aucta Pharmaceuticals

Aucta Pharmaceuticals

United States 67 employees Updated 9 July 2026

Aucta Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 9 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA and NMPA (CN). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 3 October 2025 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
9
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 3 October 2025 VAI US FDA
  • 9 June 2025 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Piscataway, United States 3015204529
Basking Ridge, United States 3029416323

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 8 2
NMPA (CN) 1 None

Questions about Aucta Pharmaceuticals

Does Aucta Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Aucta Pharmaceuticals. It does have 9 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Aucta Pharmaceuticals FDA-registered?
2 sites operated by Aucta 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 Aucta Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 3 October 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Aucta Pharmaceuticals manufacture?
2 registered sites are on record, in United States (Piscataway and Basking Ridge). Every site is listed on this page with the register it came from.
Which regulators recognise Aucta Pharmaceuticals'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 3 October 2025.

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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