Novo Nordisk 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
- Hallas Alle 1, Kalundborg, Sjaelland 4400, Denmark (DNK)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3002807751 · DUNS 305156788
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-06-10
- VAIBlood and Blood Products2023-05-04
- VAIDrug Quality Assurance2022-12-02
- NAIDrug Quality Assurance2019-09-06
- NAIDrug Quality Assurance2017-08-29
- NAIDrug Quality Assurance2014-03-07
- VAIHuman Cellular, Tissue, and Gene Therapies2013-05-10
- VAIDrug Quality Assurance2012-03-09
- VAIBlood and Blood Products2011-02-08
- VAIHuman Cellular, Tissue, and Gene Therapies2009-02-24
Drugs this plant is listed as making
1 distinct drugs across 2 products name this site in their FDA label.
- liraglutidein shortageNovo Nordisk Pharmaceutical Industries, LP
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.