Patheon Italia S.p.A
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
- 2° Trav. SX Via Morolense, 5, Ferentino, - 03013, Italy (ITA)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 3004110157 · DUNS 434078638
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIBlood and Blood Products2026-01-30
- NAIBlood and Blood Products2022-06-14
- VAIDrug Quality Assurance2022-02-25
- VAIDrug Quality Assurance2018-09-21
- NAIBlood and Blood Products2016-10-31
- VAIDrug Quality Assurance2015-12-16
- OAIDrug Quality Assurance2015-05-19
- VAIBlood and Blood Products2013-10-31
- VAIDrug Quality Assurance2013-06-21
- VAIDrug Quality Assurance2011-11-11
- VAIBlood and Blood Products2011-05-30
- NAIDrug Quality Assurance2009-06-22
Drugs this plant is listed as making
8 distinct drugs across 21 products name this site in their FDA label.
- dantrolene sodiumUswm, Llc
- defibrotide sodiumJazz Pharmaceuticals, Inc.
- diatrizoate meglumineBracco Diagnostics Inc
- Efgartigimod Alfaargenx US
- efgartigimod alfa and hyaluronidase (human recombinant)argenx US
- gadobenate dimeglumineBracco Diagnostics Inc
- Iomeprol InjectionBracco Diagnostics Inc
- IopamidolBracco Diagnostics 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.