Xellia Pharmaceuticals ApS
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
- Dalslandsgade 11, Copenhagen S, Region Hovedstaden 2300, Denmark (DNK)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3002806860 · DUNS 305814345
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2021-10-28
- VAIDrug Quality Assurance2019-10-25
- VAIDrug Quality Assurance2018-05-08
- VAIDrug Quality Assurance2016-03-15
- VAIDrug Quality Assurance2014-05-06
- VAIDrug Quality Assurance2012-10-16
- VAIDrug Quality Assurance2010-02-11
Drugs this plant is listed as making
2 distinct drugs across 5 products name this site in their FDA label.
- Vancomycin HydrochlorideSamson Medical Technologies 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.