LEO Pharma 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
- Industriparken 55, Ballerup, Region Hovedstaden 2750, Denmark (DNK)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3002807496 · DUNS 306218108
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-09-26
- VAIDrug Quality Assurance2021-06-17
- VAIDrug Quality Assurance2014-03-21
- VAIDrug Quality Assurance2011-09-15
- VAIBioresearch Monitoring2011-07-15
- OAIDrug Quality Assurance2009-06-16
Drugs this plant is listed as making
1 distinct drugs across 2 products name this site in their FDA label.
- tralokinumab-ldrmLEO Pharma 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.