Suppliers / Astrazeneca Ab

Astrazeneca Ab

Sweden AZN Updated 9 July 2026

Astrazeneca Ab is an API and finished-dose manufacturer based in Sweden. It holds 3 active US drug master files and one valid CEP across a filed portfolio of 2 molecules. Its filings concentrate with Health Canada, MEDSAFE (NZ) and MPA (SE). Its GMP standing is certified by EMA, MFDS (Korea) and BPOM (ID), among 9 authorities. Its most recent recorded inspection, by US FDA, closed on 27 April 2023 as VAI.

3
active US DMFs
1
valid CEPs
12
registered plants 1 with an FDA FEI number
2,910
filings across 37 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 27 April 2023 VAI US FDA
  • 1 December 2022 VAI US FDA
  • 1 December 2022 VAI US FDA
  • 23 February 2020 VAI US FDA
  • 6 December 2019 VAI US FDA
  • 11 October 2019 VAI US FDA
  • 30 August 2019 VAI US FDA
  • 7 December 2017 VAI US FDA

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

Registered plants

Site FDA FEI
Macclesfield, United Arab Emirates Not on file
Sodertalje, United Arab Emirates Not on file
Baar, Switzerland Not on file
Naucalpan De Juarez, Mexico, Colombia Not on file
United Kingdom, United Kingdom 3002850317
-, Indonesia Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Omeprazole EDQM, US FDA 3
Budesonide US FDA 1

Also appears on these molecule pages

Acalabrutinib finished dose Amitriptyline finished dose Atenolol finished dose Bicalutamide finished dose Budesonide API Candesartan finished dose Candesartan Cilexetil finished dose Dapagliflozin finished dose Dapagliflozin Propanediol finished dose Empagliflozin finished dose Epinephrine finished dose Esomeprazole finished dose
Show 17 more molecule pages
Exenatide finished dose Felodipine finished dose Fluticasone finished dose Formoterol finished dose Fulvestrant finished dose Gefitinib finished dose Metoprolol finished dose Olaparib finished dose Omeprazole API Prilocaine finished dose Roflumilast finished dose Saxagliptin finished dose Sodium Zirconium Cyclosilicate finished dose Tamoxifen finished dose Terbutaline finished dose Ticagrelor finished dose Zolmitriptan finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 532 None
MEDSAFE (NZ) 298 None
MPA (SE) 224 None
EMA 210 11
AIFA (IT) 207 None
FAMHP (BE) 152 None
MFDS (Korea) None 10
BPOM (ID) None 8
ANVISA (Brazil) None 7
NCELS (KZ) None 5
NAFDAC (NG) None 4
HSA (SG) None 2
EDA (EG) None 1
MCAZ (ZW) None 1

Scale

Year Revenue Exports Destinations
2024 $1.1B Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Astrazeneca Ab

Does Astrazeneca Ab hold a US DMF or a CEP?
Astrazeneca Ab holds 3 active US drug master files and 1 valid CEP. 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.
Is Astrazeneca Ab FDA-registered?
One site operated by Astrazeneca Ab carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Astrazeneca Ab's last inspection go?
The most recent inspection on record closed on 27 April 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Astrazeneca Ab manufacture?
12 registered sites are on record, in United Arab Emirates, Switzerland, Colombia and United Kingdom (Macclesfield, Sodertalje and Baar among others). Every site is listed on this page with the register it came from.
What does Astrazeneca Ab make?
2 molecules are on record against Astrazeneca Ab, including Omeprazole and Budesonide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Astrazeneca Ab's GMP?
Current GMP certificates are on record from EMA, MFDS (Korea), BPOM (ID), ANVISA (Brazil), NCELS (KZ) and 4 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

  • 84 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 27 April 2023.

Comparable suppliers

Cipla shares 2 molecules Apitoria Pharma shares 1 molecule Hetero shares 1 molecule Dr Reddy's Laboratories shares 1 molecule Alivus Life Sciences shares 1 molecule

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
Company filings
Revenue as reported