Suppliers / Gsk Vaccines

Gsk Vaccines

United Kingdom Updated 9 July 2026

Gsk Vaccines is an API and finished-dose manufacturer based in United Kingdom. It holds 10 active US drug master files across a filed portfolio of 9 molecules. Its filings concentrate with US FDA, Health Canada and INFARMED (PT). Its GMP standing is certified by MHRA (UK), ZLG (DE) and NAFDAC (NG), among 14 authorities. Its most recent recorded inspection, by US FDA, closed on 20 February 2026 as NAI.

10
active US DMFs
0
valid CEPs
12
registered plants
2,080
filings across 37 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
0 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 20 February 2026 NAI US FDA
  • 6 December 2024 VAI US FDA
  • 19 April 2024 VAI US FDA
  • 6 March 2024 VAI US FDA
  • 26 October 2023 VAI US FDA
  • 13 October 2023 VAI US FDA
  • 23 June 2023 NAI US FDA
  • 20 June 2023 NAI US FDA

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

Registered plants

Site FDA FEI
Hertfordshire, United Arab Emirates Not on file
Barnard Castle, United Arab Emirates Not on file
Barnard Castle, United Arab Emirates Not on file
Aranda De Duero(Burgos), United Arab Emirates Not on file
Parma, United Arab Emirates Not on file
Hertfordshire, United Arab Emirates Not on file

6 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 345 7
Health Canada 321 None
INFARMED (PT) 212 None
EDA (EG) 199 None
ARCSA (EC) 111 None
EMA 108 4
MHRA (UK) None 20
ZLG (DE) None 14
NAFDAC (NG) None 10
ANVISA (Brazil) None 9
BPOM (ID) None 6
MFDS (Korea) None 4
TMDA (TZ) None 3
SAHPRA (ZA) None 3
COFEPRIS (MX) None 2
HSA (SG) None 1
NCELS (KZ) None 1
FDA (GH) None 1

Scale

Year Revenue Exports Destinations
2022 $640.0B Not reported Not reported
2021 $520.0B Not reported Not reported
2020 $6.5B Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer.

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Open risk flags

  • 7 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 20 February 2026.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Company filings
Revenue as reported