Patheon Austria GmbH & CoKG
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
- St.-Peter-Strasse 25, Linz, 4020, Austria (AUT)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3002806853 · DUNS 300398976
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-09-12
- VAIDrug Quality Assurance2018-11-30
- NAIDrug Quality Assurance2015-05-29
- VAIDrug Quality Assurance2012-06-01
- NAIDrug Quality Assurance2009-05-08
Drugs this plant is listed as making
5 distinct drugs across 5 products name this site in their FDA label.
- colesevelam hydrochlorideBionpharma Inc.
- Meropenem-VaborbactamMelinta Therapeutics, LLC
- PacritinibSobi, Inc.
- PonesimodJanssen Pharmaceuticals, Inc
- tapinarofOrganon 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.