Syntese A/S
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
- Denmark
- Registered address
- Industriholmen 13, Hvidovre, 2650, Denmark (DNK)
- Operations here
- analysisapi manufacturelabel
- FDA identifiers
- FEI 3005574971 · DUNS 305104267
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-05-12
- VAIDrug Quality Assurance2016-06-17
- VAIDrug Quality Assurance2014-03-20
Drugs this plant is listed as making
1 distinct drugs across 2 products name this site in their FDA label.
- mesalamineTakeda Pharmaceuticals America, 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.