AstraZeneca AB
AstraZeneca AB is a drug establishment in Sodertalje, Sweden, registered with the US FDA under FEI 3003342394. Its registered operations are: Analytical testing, Labelling, Drug manufacture, Packaging. 17 EU/UK GMP certificates are matched to this site, 13 inspected within the last three years.
Sources: FDA Drug Establishments Current Registration Site (checked 2 Nov 2026); EudraGMDP; MHRA GMDP. Methodology
Registered operations
Business operations this establishment declares in its FDA registration. Registration is not an approval and says nothing about EU or UK GMP status.
GMP documents matched to this site (17)
| Document | Authority | Inspection | Source |
|---|---|---|---|
SE-H-GMP-26-055375 GMP certificate | Competent authority of Sweden | 29 Apr 2026 within 3-year review window | EudraGMDP |
SE-HI-GMP-26-055377 GMP certificate | Competent authority of Sweden | 29 Apr 2026 within 3-year review window | EudraGMDP |
SE-HI-GMP-26-016815 GMP certificate | Competent authority of Sweden | 12 Dec 2025 within 3-year review window | EudraGMDP |
SE-H-GMP-26-016814 GMP certificate | Competent authority of Sweden | 12 Dec 2025 within 3-year review window | EudraGMDP |
SE-H-GMP-25-008053 GMP certificate | Competent authority of Sweden | 24 Oct 2024 within 3-year review window | EudraGMDP |
SE-HI-GMP-24-036233 GMP certificate | Competent authority of Sweden | 26 Jan 2024 within 3-year review window | EudraGMDP |
SE-H-GMP-24-036232 GMP certificate | Competent authority of Sweden | 26 Jan 2024 within 3-year review window | EudraGMDP |
SE-H-GMP-23-072770 GMP certificate | Competent authority of Sweden | 7 Dec 2023 within 3-year review window | EudraGMDP |
SE-HI-GMP-24-012607 GMP certificate | Competent authority of Sweden | 7 Dec 2023 within 3-year review window | EudraGMDP |
5.9.1-2023-092406 GMP certificate | Competent authority of Sweden | 1 Dec 2023 within 3-year review window | EudraGMDP |
SE-H-GMP-25-024276 GMP certificate | Competent authority of Sweden | 1 Dec 2023 within 3-year review window | EudraGMDP |
SE-HI-GMP-25-024397 GMP certificate | Competent authority of Sweden | 1 Dec 2023 within 3-year review window | EudraGMDP |
5.9.1-2023-092403 GMP certificate | Competent authority of Sweden | 1 Dec 2023 within 3-year review window | EudraGMDP |
5.9.1-2023-083290 GMP certificate | Competent authority of Sweden | 1 Dec 2022 outside 3-year review window | EudraGMDP |
5.9.1-2023-095141 GMP certificate | Competent authority of SWEDEN | 1 Oct 2021 outside 3-year review window | EudraGMDP |
5.9.1-2023-104592 GMP certificate | Competent authority of SWEDEN | 16 Apr 2021 outside 3-year review window | EudraGMDP |
5.9.1-2023-102851 GMP certificate | Competent authority of SWEDEN | 16 Apr 2021 outside 3-year review window | EudraGMDP |
A GMP document is matched to this site when its address names the site's street and its city or postcode. In our latest internal review 59 of 60 sampled matches were the right site (not yet independently reviewed; measured match quality). Check the certificate's own address before relying on it. The three-year review window is the EMA guideline default after an inspection, not an official expiry date.
What this page does not show
- Which substances are made here: DMFs and CEPs are filed by organisations, not sites, so we do not link substances to this site.
- Capacity, scale, price or current availability: no regulator publishes these.
- FDA inspection classifications for this site, which are not yet linked.