Sandoz GmbH
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
- Austria
- Registered address
- Biochemiestrasse 10, Kundl, Tyrol A-6250, Austria (AUT)
- Operations here
- analysisapi manufacturelabelmanufacturepackrelabelrepack
- FDA identifiers
- FEI 3002806523 · DUNS 300220969
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-11-17
- VAIDrug Quality Assurance2018-09-18
- VAIDrug Quality Assurance2016-11-17
- VAIDrug Quality Assurance2016-01-29
- VAIDrug Quality Assurance2015-04-30
- VAIDrug Quality Assurance2014-09-16
- VAIDrug Quality Assurance2012-10-12
- VAIDrug Quality Assurance2010-07-29
- NAIDrug Quality Assurance2009-07-08
Drugs this plant is listed as making
3 distinct drugs across 3 products name this site in their FDA label.
- CeftazidimeHospira, Inc.
- vonoprazan fumarate and amoxicillinPhathom Pharmaceuticals Inc.
- vonoprazan fumarate, amoxicillin and clarithromycinPhathom Pharmaceuticals Inc.
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.