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.

What they file, and where

Molecule Regulators Docs
Fluticasone Propionate US FDA 2
Albuterol US FDA 1
Ceftazidime US FDA 1
Cefuroxime US FDA 1
Fluticasone Furoate US FDA 1
Paroxetine US FDA 1
Salmeterol US FDA 1
Umeclidinium Bromide US FDA 1
Vilanterol US FDA 1

Also appears on these molecule pages

Acyclovir finished dose Albuterol API Amoxicillin finished dose Ampicillin finished dose Atovaquone finished dose Beclomethasone finished dose Betamethasone finished dose Bupropion finished dose Cefalotin finished dose Cefazolin finished dose Ceftazidime API Cefuroxime API
Show 43 more molecule pages
Chlorphenamine finished dose Chlorpheniramine finished dose Chlorpromazine finished dose Cimetidine finished dose Clavulanic Acid finished dose Clobetasol finished dose Cloxacillin finished dose Codeine finished dose Dextroamphetamine finished dose Diclofenac finished dose Digoxin finished dose Eltrombopag finished dose Fluticasone API Isradipine finished dose Labetalol finished dose Lamivudine finished dose Lamotrigine finished dose Leucovorin finished dose Loratadine finished dose Mupirocin finished dose Neomycin finished dose Nicotine finished dose Ondansetron finished dose Oxacillin finished dose Paroxetine API Permethrin finished dose Phentermine finished dose Phylloquinone finished dose Polymyxin B finished dose Proguanil finished dose Propafenone finished dose Pseudoephedrine finished dose Ranitidine finished dose Ropinirole finished dose Salbutamol API Salmeterol API Sumatriptan finished dose Terbinafine finished dose Umeclidinium API Valaciclovir finished dose Valacyclovir finished dose Vilanterol API Xylometazoline finished dose

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

Questions about Gsk Vaccines

Does Gsk Vaccines hold a US DMF or a CEP?
Gsk Vaccines holds 10 active US drug master files. 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.
How did Gsk Vaccines's last inspection go?
The most recent inspection on record closed on 20 February 2026 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Gsk Vaccines manufacture?
12 registered sites are on record, in United Arab Emirates and Belgium (Hertfordshire, Barnard Castle and Aranda De Duero(burgos) among others). Every site is listed on this page with the register it came from.
What does Gsk Vaccines make?
9 molecules are on record against Gsk Vaccines, including Fluticasone Propionate, Albuterol, Ceftazidime and Cefuroxime. Each links through to that molecule's full manufacturer list.
Which regulators recognise Gsk Vaccines's GMP?
Current GMP certificates are on record from MHRA (UK), ZLG (DE), NAFDAC (NG), ANVISA (Brazil), US FDA and 9 more. 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

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

Comparable suppliers

Cipla shares 6 molecules Lupin shares 6 molecules Melody Healthcare shares 5 molecules Neuland Laboratories shares 4 molecules Vamsi Labs shares 4 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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