FUJIFILM Diosynth Biotechnologies Denmark 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
- Biotek Alle 1, Hillerod, 3400, Denmark (DNK)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3006339887 · DUNS 307258082
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-06-30
- VAIDrug Quality Assurance2019-05-10
- NAIDrug Quality Assurance2017-06-16
- VAIDrug Quality Assurance2014-08-19
- NAIDrug Quality Assurance2011-05-27
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- DaratumumabJanssen Biotech, 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.