Janssen Biotech, Inc.
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
- United States
- Registered address
- 200 Great Valley Pkwy, Malvern, Pennsylvania (PA) 19355-1307, United States (USA)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3001610451 · DUNS 038978363
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-07-29
- NAIHuman Cellular, Tissue, and Gene Therapies2025-03-10
- NAIBioresearch Monitoring2018-11-30
- VAIDrug Quality Assurance2018-03-05
- VAIBioresearch Monitoring2017-11-21
- NAIBioresearch Monitoring2017-02-27
- NAIBioresearch Monitoring2015-08-19
- VAIDrug Quality Assurance2014-09-24
- NAIBioresearch Monitoring2012-09-25
- VAIDrug Quality Assurance2012-06-15
- VAIDrug Quality Assurance2011-05-20
- VAIBioresearch Monitoring2010-10-26
- VAIDrug Quality Assurance2009-08-18
- NAIBioresearch Monitoring2008-11-13
Drugs this plant is listed as making
8 distinct drugs across 15 products name this site in their FDA label.
- DaratumumabJanssen Biotech, Inc.
- GuselkumabJanssen Biotech, Inc.
- InfliximabJanssen Biotech, Inc.
- nipocalimab-aahuJanssen Biotech, Inc.
- SiltuximabRecordati Rare Diseases, Inc.
- talquetamabJanssen Biotech, Inc.
- teclistamab-cqyvJanssen 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.