Suppliers / indivior uk

indivior uk

United Kingdom 2 duplicate records merged Updated 9 July 2026

indivior uk is a 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

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

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Open risk flags

  • The most recent inspection outcome was VAI, on 13 September 2021.

Sources on this page

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