Suppliers / Norton Healthcare

Norton Healthcare

United Kingdom Updated 9 July 2026

Norton Healthcare is a finished-dose manufacturer based in United Kingdom. It appears in 27 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with MEDSAFE (NZ), SAHPRA (ZA) and EMA. Its GMP standing is certified by MHRA (UK) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 10 February 2023 as NAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
27
filings across 7 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

  • 10 February 2023 NAI US FDA
  • 26 November 2021 VAI US FDA
  • 13 December 2018 NAI US FDA
  • 4 May 2016 NAI US FDA
  • 11 November 2014 VAI US FDA
  • 6 November 2012 VAI US FDA
  • 19 November 2010 VAI US FDA
  • 22 April 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Runcorn, United Arab Emirates Not on file
RUNCORN, United Kingdom Not on file
RUNCORN, United Kingdom Not on file
United Kingdom, United Kingdom 3003925187

Filings and GMP by regulator

Regulator Filings GMP certificates
MEDSAFE (NZ) 16 None
SAHPRA (ZA) 4 None
EMA 2 None
NCELS (KZ) 2 None
INFARMED (PT) 1 None
MPA (SE) 1 None
MHRA (UK) None 4
ANVISA (Brazil) None 1

Questions about Norton Healthcare

Does Norton Healthcare hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Norton Healthcare. It does have 27 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Norton Healthcare FDA-registered?
One site operated by Norton Healthcare 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 Norton Healthcare's last inspection go?
The most recent inspection on record closed on 10 February 2023 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Norton Healthcare manufacture?
4 registered sites are on record, in United Arab Emirates and United Kingdom (Runcorn, Runcorn and United Kingdom among others). Every site is listed on this page with the register it came from.
Which regulators recognise Norton Healthcare's GMP?
Current GMP certificates are on record from MHRA (UK) and ANVISA (Brazil). 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 February 2023.

Sources on this page

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