Janssen Pharmaceutical Sciences Unlimited Company
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
- Ireland
- Registered address
- LITTLE ISLAND INDUSTRIAL ESTATE T45 P663, CO CORK, , Ireland (IRL)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3002807361 · DUNS 985639841
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-10-27
- VAIDrug Quality Assurance2018-11-09
- NAIDrug Quality Assurance2017-03-24
- NAIDrug Quality Assurance2014-03-21
- VAIDrug Quality Assurance2009-04-21
Drugs this plant is listed as making
9 distinct drugs across 35 products name this site in their FDA label.
- amivantamab-vmjwJanssen Biotech, Inc.
- darunavirJanssen Products LP
- DARUNAVIR ETHANOLATE and COBICISTATJanssen Products, LP
- Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LP
- ItraconazolePatriot Pharmaceuticals
- paliperidoneJanssen Pharmaceuticals, Inc.
- paliperidone palmitateJanssen Pharmaceuticals, 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.