Janssen Biologics B.V.
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
- Netherlands
- Registered address
- Einsteinweg101, Leiden, 2333 CB, Netherlands (NLD)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3002806632 · DUNS 409612918
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-06-01
- VAIDrug Quality Assurance2018-10-11
- NAIDrug Quality Assurance2018-06-15
- NAIDrug Quality Assurance2016-05-27
- VAIDrug Quality Assurance2014-07-11
- VAIDrug Quality Assurance2012-09-28
- NAIDrug Quality Assurance2010-07-06
Drugs this plant is listed as making
10 distinct drugs across 20 products name this site in their FDA label.
- DaratumumabJanssen Biotech, Inc.
- golimumabJanssen Biotech, Inc.
- GuselkumabJanssen Biotech, Inc.
- InfliximabJanssen Biotech, Inc.
- nipocalimab-aahuJanssen Biotech, Inc.
- SiltuximabRecordati Rare Diseases, Inc.
- talquetamabJanssen Biotech, Inc.
- teclistamab-cqyvJanssen Biotech, Inc.
- ustekinumabJanssen 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.