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
- Viale Gian Battista Stucchi 110, Monza, - 20900, Italy (ITA)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 3003065803 · DUNS 338336589
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIVaccines and Allergenic Products2023-09-29
- VAIDrug Quality Assurance2023-05-26
- VAIDrug Quality Assurance2023-01-26
- VAIDrug Quality Assurance2022-04-08
- VAIDrug Quality Assurance2019-07-05
- NAIDrug Quality Assurance2018-02-06
- VAIDrug Quality Assurance2016-05-20
- VAIDrug Quality Assurance2014-04-08
- VAIDrug Quality Assurance2013-06-11
- VAIDrug Quality Assurance2011-06-21
- NAIDrug Quality Assurance2009-07-01
Drugs this plant is listed as making
11 distinct drugs across 13 products name this site in their FDA label.
- abataceptE.R. Squibb & Sons, L.L.C.
- anakinraSwedish Orphan Biovitrum AB (publ)
- BrodalumabBausch Health US LLC
- caplacizumabGenzyme Corporation
- epoprostenolActelion Pharmaceuticals US, Inc.
- InfliximabJanssen Biotech, Inc.
- minocycline hydrochlorideMelinta Therapeutics, LLC
- oritavancinMelinta Therapeutics, LLC
- oritavancin diphosphateMelinta Therapeutics, LLC
- remimazolam besylateAcacia Pharma, Ltd.
- TigecyclineWyeth Pharmaceuticals LLC, a subsidiary of Pfizer 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.