Patheon Inc.
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
- Canada
- Registered address
- 2100 Syntex Court, Mississauga, Ontario L5N 7K9, Canada (CAN)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3000264888 · DUNS 240769596
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-02-24
- VAIDrug Quality Assurance2019-04-12
- NAIDrug Quality Assurance2016-12-02
- VAIDrug Quality Assurance2015-11-13
- VAIDrug Quality Assurance2015-01-30
- VAIDrug Quality Assurance2013-04-26
- VAIDrug Quality Assurance2011-02-18
Drugs this plant is listed as making
16 distinct drugs across 24 products name this site in their FDA label.
- abiraterone acetateJanssen Biotech, Inc.
- alosetron hydrochlorideSebela Pharmaceuticals Inc.
- auranofinSebela Pharmaceuticals Inc.
- bosentanActelion Pharmaceuticals US, Inc.
- cabozantinibExelixis, Inc.
- DARUNAVIR ETHANOLATE and COBICISTATJanssen Products, LP
- Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LP
- dextromethorphan hydrobromide and quinidine sulfateAvanir Pharmaceuticals, Inc.
- Norethindrone Acetate/Ethinyl EstradiolMillicent US, Inc.
- Norgestrel and Ethinyl EstradiolMayne Pharma Inc.
- oteseconazoleMycovia Pharmaceuticals, Inc.
- ponatinib hydrochlorideTakeda Pharmaceuticals America, Inc.
- rilzabrutinibGenzyme Corporation
- rivaroxabanJanssen Pharmaceuticals, Inc.
- sonidegibSun Pharmaceutical Industries, 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.