Suppliers / indivior uk

indivior uk

United Kingdom 2 duplicate records merged Updated 9 July 2026

indivior uk is an API and finished-dose manufacturer based in United Kingdom. It holds one active US drug master file. Its filings concentrate with AIFA (IT), FAMHP (BE) and US FDA. Its GMP standing is certified by MHRA (UK). Its most recent recorded inspection, by US FDA, closed on 13 September 2021 as VAI.

1
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
106
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 13 September 2021 VAI US FDA
  • 7 September 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
HULL, United Kingdom Not on file
United Kingdom, United Kingdom 3010680503

What they file, and where

Molecule Regulators Docs
Buprenorphine SFDA (Saudi Arabia), US FDA 2

Also appears on these molecule pages

Buprenorphine API Naloxone finished dose Risperidone finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 25 None
FAMHP (BE) 18 None
US FDA 14 None
MPA (SE) 12 None
Health Canada 10 None
INFARMED (PT) 10 None
MHRA (UK) None 5

Questions about indivior uk

Does indivior uk hold a US DMF or a CEP?
indivior uk holds 1 active US drug master file. 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 indivior uk FDA-registered?
One site operated by indivior uk 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 indivior uk's last inspection go?
The most recent inspection on record closed on 13 September 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does indivior uk manufacture?
2 registered sites are on record, in United Kingdom (Hull and United Kingdom). Every site is listed on this page with the register it came from.
What does indivior uk make?
1 molecule is on record against indivior uk, including Buprenorphine. Each links through to that molecule's full manufacturer list.
Which regulators recognise indivior uk'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 13 September 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