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.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| 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.
| Molecule | Regulators | Docs |
|---|---|---|
| Omeprazole | EDQM, US FDA | 3 |
| Budesonide | US FDA | 1 |
Also appears on these molecule pages
| 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 |
| MCAZ (ZW) | None | 1 |
| EDA (EG) | None | 1 |
| 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 We do not publish the identity of any buyer.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.
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