Suppliers / AstraZeneca UK

AstraZeneca UK

United Kingdom 2 duplicate records merged Updated 9 July 2026

AstraZeneca UK is a finished-dose manufacturer based in United Kingdom. It appears in 722 regulatory filings across 14 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), EFDA (ET) and TMDA (TZ). Its GMP standing is certified by TMDA (TZ), MHRA (UK) and ANVISA (Brazil), among 6 authorities.

0
active US DMFs
0
valid CEPs
5
registered plants
722
filings across 14 regulators

Registered plants

Site FDA FEI
Macclesfield, United Arab Emirates Not on file
BRISTOL, United Kingdom Not on file
MACCLESFIELD, United Kingdom Not on file
BRISTOL, United Kingdom Not on file
Riyadh, Saudi Arabia Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) 549 5
EFDA (ET) 31 None
TMDA (TZ) 24 6
EMA 20 None
MINSA (CR) 19 None
SFDA (Saudi Arabia) 13 None
ANVISA (Brazil) None 3
MFDS (Korea) None 2
NCELS (KZ) None 1
NAFDAC (NG) None 1

Questions about AstraZeneca UK

Does AstraZeneca UK hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for AstraZeneca UK. It does have 722 filings with 14 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does AstraZeneca UK manufacture?
5 registered sites are on record, in United Arab Emirates, United Kingdom and Saudi Arabia (Macclesfield, Bristol and Macclesfield among others). Every site is listed on this page with the register it came from.
Which regulators recognise AstraZeneca UK's GMP?
Current GMP certificates are on record from TMDA (TZ), MHRA (UK), ANVISA (Brazil), MFDS (Korea), NCELS (KZ) and 1 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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Sources on this page

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