Janssen Pharmaceuticals 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
- 1000 Route 202 South, Raritan, New Jersey (NJ) 08869-0602, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 2211100 · DUNS 868441320
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIHuman Cellular, Tissue, and Gene Therapies2023-12-14
- NAIDrug Quality Assurance2022-06-17
- NAIDrug Quality Assurance2017-01-26
- NAIBioresearch Monitoring2016-01-22
- NAIBioresearch Monitoring2013-05-21
- NAIDrug Quality Assurance2012-06-19
- NAIDrug Quality Assurance2011-08-22
- NAIDrug Quality Assurance2010-08-06
- VAIDrug Quality Assurance2009-01-15
Drugs this plant is listed as making
3 distinct drugs across 6 products name this site in their FDA label.
- Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LP
- Methylphenidate hydrochloridein shortageJanssen Pharmaceuticals, Inc.
- rivaroxabanJanssen Pharmaceuticals, 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.