Suppliers / Smithkline Beecham

Smithkline Beecham

United Kingdom Updated 9 July 2026

Smithkline Beecham is an API and finished-dose manufacturer based in United Kingdom. It holds 2 valid CEPs across a filed portfolio of 2 molecules. Its filings concentrate with Health Canada, EDA (EG) and EMA. Its GMP standing is certified by BPOM (ID), ANVISA (Brazil) and NAFDAC (NG), among 4 authorities.

0
active US DMFs
2
valid CEPs
6
registered plants
307
filings across 16 regulators

Registered plants

Site FDA FEI
Irvine, United Kingdom Not on file
IRVINE, United Kingdom Not on file
WORTHING, United Kingdom Not on file
WORTHING, United Kingdom Not on file
Irvine, United Kingdom Not on file
-, Indonesia Not on file

What they file, and where

Molecule Regulators Docs
Potassium Clavulanate EDQM 2
Abacavir SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Abacavir API Buspirone finished dose Cefprozil finished dose Econazole finished dose Isradipine finished dose Nabumetone finished dose Nizatidine finished dose Potassium Clavulanate API Ropinirole finished dose Sulbactam finished dose Triamcinolone Acetonide finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 105 None
EDA (EG) 84 None
EMA 23 None
INFARMED (PT) 18 None
MPA (SE) 18 None
US FDA 10 None
BPOM (ID) None 2
ANVISA (Brazil) None 1
NAFDAC (NG) None 1
FDA (GH) None 1

Questions about Smithkline Beecham

Does Smithkline Beecham hold a US DMF or a CEP?
Smithkline Beecham holds 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.
Where does Smithkline Beecham manufacture?
6 registered sites are on record, in United Kingdom and Indonesia (Irvine, Irvine and Worthing among others). Every site is listed on this page with the register it came from.
What does Smithkline Beecham make?
2 molecules are on record against Smithkline Beecham, including Potassium Clavulanate and Abacavir. Each links through to that molecule's full manufacturer list.
Which regulators recognise Smithkline Beecham's GMP?
Current GMP certificates are on record from BPOM (ID), ANVISA (Brazil), NAFDAC (NG) and FDA (GH). 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

  • 87 active litigation matters are on record.

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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