Gentium S.r.L
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
- Piazza XX Settembre, 2, Villa Guardia, CO 22079, Italy (ITA)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3003744181 · DUNS 432729114
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2021-12-17
- VAIDrug Quality Assurance2017-06-15
- NAIDrug Quality Assurance2015-12-04
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- defibrotide sodiumJazz 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.