Suppliers / Novacyl

Novacyl

France 3 duplicate records merged Updated 9 July 2026

Novacyl is an API manufacturer based in France. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 24 November 2023 as VAI.

0
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
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 24 November 2023 VAI US FDA
  • 2 February 2023 VAI US FDA
  • 2 March 2018 VAI US FDA
  • 30 June 2016 VAI US FDA
  • 4 July 2014 VAI US FDA
  • 25 October 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
France, France 3009804152
France, France 3002807997

What they file, and where

Molecule Regulators Docs
Salicylic Acid PMDA (Japan) 1
アスピリン PMDA (Japan) 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Novacyl

Is Novacyl FDA-registered?
2 sites operated by Novacyl 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 Novacyl's last inspection go?
The most recent inspection on record closed on 24 November 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Novacyl manufacture?
2 registered sites are on record, in France (France among others). Every site is listed on this page with the register it came from.
What does Novacyl make?
2 molecules are on record against Novacyl, including Salicylic Acid and アスピリン. Each links through to that molecule's full manufacturer list.
Which regulators recognise Novacyl'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 24 November 2023.

Comparable suppliers

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