AstraZeneca AB
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Sweden
- Registered address
- Gartunavagen, Sodertalje, 152 57, Sweden (SWE)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3003342394 · DUNS 631892705
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-12-01
- VAIDrug Quality Assurance2019-12-06
- VAIDrug Quality Assurance2017-12-07
- NAIDrug Quality Assurance2017-01-27
- VAIDrug Quality Assurance2014-03-28
- NAIDrug Quality Assurance2012-05-29
- VAIDrug Quality Assurance2010-12-10
- NAIDrug Quality Assurance2010-03-25
Drugs this plant is listed as making
2 distinct drugs across 7 products name this site in their FDA label.
- BenralizumabAstraZeneca Pharmaceuticals LP
- Metoprolol SuccinateMelinta Therapeutics, LLC
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.