Suppliers / Novel Labs

Novel Labs

United States 57 employees Updated 9 July 2026

Novel Labs is a finished-dose manufacturer based in United States. It appears in 17 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 May 2024 as NAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
17
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 17 May 2024 NAI US FDA
  • 13 January 2023 VAI US FDA
  • 30 March 2022 VAI US FDA
  • 5 November 2020 OAI US FDA
  • 8 November 2018 VAI US FDA
  • 23 February 2018 VAI US FDA
  • 8 August 2017 VAI US FDA
  • 14 February 2017 NAI US FDA

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

Registered plants

Site FDA FEI
Somerset, United States 3006271438

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 17 1

Questions about Novel Labs

Does Novel Labs hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Novel Labs. It does have 17 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Novel Labs FDA-registered?
One site operated by Novel Labs 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 Novel Labs's last inspection go?
The most recent inspection on record closed on 17 May 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file, of which 1 closed as OAI.
Where does Novel Labs manufacture?
1 registered site is on record, in United States (Somerset). Every site is listed on this page with the register it came from.
Which regulators recognise Novel Labs'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

  • 20 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 17 May 2024.

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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