Janssen Pharmaceutica NV
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
- Belgium
- Registered address
- Janssen Pharmaceuticalaan 3, Geel, B-2440, Belgium (BEL)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3002807337 · DUNS 400345889
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-10-27
- NAIDrug Quality Assurance2015-06-04
- NAIDrug Quality Assurance2013-09-12
- VAIDrug Quality Assurance2012-10-18
- NAIDrug Quality Assurance2011-05-06
- NAIDrug Quality Assurance2010-12-10
Drugs this plant is listed as making
15 distinct drugs across 34 products name this site in their FDA label.
- abiraterone acetateJanssen Biotech, Inc.
- Bedaquiline FumarateJanssen Products, LP
- cabotegravir and rilpivirineViiV Healthcare Company
- canagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.
- darunavirJanssen Products LP
- Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LP
- etravirinePatriot Pharmaceuticals
- Haloperidol DecanoateJanssen Pharmaceuticals, Inc.
- icotrokinraJanssen Biotech, Inc.
- ItraconazolePatriot Pharmaceuticals
- lazertinibJanssen Biotech, Inc.
- NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATEJanssen Biotech, Inc.
- rilpivirine hydrochlorideJanssen Products, LP
- risperidoneJanssen 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.