Suppliers / GlaxoSmithKline

GlaxoSmithKline

United States 10 duplicate records merged Updated 9 July 2026

GlaxoSmithKline is a finished-dose manufacturer based in United States. It appears in 2,375 regulatory filings across 23 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), Health Canada and SWISSMEDIC (CH). Its GMP standing is certified by TMDA (TZ), NAFDAC (NG) and MFDS (Korea), among 4 authorities.

0
active US DMFs
0
valid CEPs
8
registered plants
2,375
filings across 23 regulators

Registered plants

Site FDA FEI
Mississauga, United Arab Emirates Not on file
MISSISSAUGA, Canada Not on file
Baar, Switzerland Not on file
TIANJIN, China Not on file
Cairo, Nigeria Not on file
Nairobi, Tanzania Not on file

2 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) 863 1
Health Canada 583 None
SWISSMEDIC (CH) 166 None
DH (HK) 126 None
EMA 119 None
ANSM (FR) 118 None
TMDA (TZ) None 4
NAFDAC (NG) None 3
MFDS (Korea) None 2

Questions about GlaxoSmithKline

Does GlaxoSmithKline hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for GlaxoSmithKline. It does have 2,375 filings with 23 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does GlaxoSmithKline manufacture?
8 registered sites are on record, in United Arab Emirates, Canada, Switzerland and China (Mississauga, Mississauga and Baar among others). Every site is listed on this page with the register it came from.
Which regulators recognise GlaxoSmithKline's GMP?
Current GMP certificates are on record from TMDA (TZ), NAFDAC (NG), MFDS (Korea) and 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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Sources on this page

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