Suppliers / Nicobrand

Nicobrand

United Kingdom 34 employees Updated 9 July 2026

Nicobrand is an API manufacturer based in United Kingdom. It holds 3 active US drug master files and 2 valid CEPs across a filed portfolio of 2 molecules. Its GMP standing is certified by MHRA (UK). Its most recent recorded inspection, by US FDA, closed on 3 June 2021 as VAI.

3
active US DMFs
2
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 3 June 2021 VAI US FDA
  • 11 December 2014 NAI US FDA
  • 7 April 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Coleraine, United Kingdom Not on file
United Kingdom, United Kingdom 3002807711

What they file, and where

Molecule Regulators Docs
Nicotine EDQM, US FDA 4
Nicotine Resinate EDQM 1

Also appears on these molecule pages

Nicotine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) None 1

Questions about Nicobrand

Does Nicobrand hold a US DMF or a CEP?
Nicobrand holds 3 active US drug master files and 2 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Nicobrand FDA-registered?
One site operated by Nicobrand 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 Nicobrand's last inspection go?
The most recent inspection on record closed on 3 June 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Nicobrand manufacture?
2 registered sites are on record, in United Kingdom (Coleraine and United Kingdom). Every site is listed on this page with the register it came from.
What does Nicobrand make?
2 molecules are on record against Nicobrand, including Nicotine and Nicotine Resinate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Nicobrand's GMP?
Current GMP certificates are on record from MHRA (UK). 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 June 2021.

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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