Janssen Cilag SpA
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
- Italy
- Registered address
- Via C. Janssen, Borgo San Michele, Latina 04100, Italy (ITA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3003164454 · DUNS 542797928
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-09-27
- VAIDrug Quality Assurance2022-01-27
- VAIDrug Quality Assurance2018-05-18
- NAIDrug Quality Assurance2016-04-29
- VAIDrug Quality Assurance2014-09-11
- NAIDrug Quality Assurance2010-10-21
Drugs this plant is listed as making
12 distinct drugs across 28 products name this site in their FDA label.
- abiraterone acetateJanssen Biotech, Inc.
- canagliflozin and metformin hydrochlorideJanssen Pharmaceuticals, Inc.
- darunavirJanssen Products LP
- Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LP
- ErdafitinibJanssen Products LP
- etravirineJanssen Products LP
- icotrokinraJanssen Biotech, Inc.
- lazertinibJanssen Biotech, Inc.
- macitentan and tadalafilActelion Pharmaceuticals US, Inc.
- NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATEJanssen Biotech, Inc.
- rilpivirine hydrochlorideJanssen Products, LP
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.