Suppliers / Nova Laboratories

Nova Laboratories

United Kingdom 3 duplicate records merged Updated 9 July 2026

Nova Laboratories is a finished-dose manufacturer based in United Kingdom. It appears in 176 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), MHRA (UK) and SFDA (Saudi Arabia). Its GMP standing is certified by MHRA (UK) and US FDA. Its most recent recorded inspection, by US FDA, closed on 23 August 2024 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
176
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 23 August 2024 VAI US FDA
  • 12 March 2019 VAI US FDA
  • 28 February 2019 VAI US FDA
  • 3 March 2016 VAI US FDA
  • 6 December 2013 VAI US FDA

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

Registered plants

Site FDA FEI
WIGSTON, United Kingdom Not on file
United Kingdom, United Kingdom 3000323524

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 163 None
MHRA (UK) 4 5
SFDA (Saudi Arabia) 2 None
US FDA 2 1
AEMPS (ES) 1 None
DMP (NO) 1 None

Questions about Nova Laboratories

Does Nova Laboratories hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Nova Laboratories. It does have 176 filings with 9 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Nova Laboratories FDA-registered?
One site operated by Nova Laboratories 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 Nova Laboratories's last inspection go?
The most recent inspection on record closed on 23 August 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Nova Laboratories manufacture?
2 registered sites are on record, in United Kingdom (Wigston and United Kingdom). Every site is listed on this page with the register it came from.
Which regulators recognise Nova Laboratories's GMP?
Current GMP certificates are on record from MHRA (UK) and 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 23 August 2024.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates