Catalent Ontario Limited
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
- 2125 Ambassador Drive, Windsor, Ontario N9C 3R5, Canada (CAN)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3000118564 · DUNS 248441727
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-01-20
- VAIDrug Quality Assurance2019-02-08
- OAIBioresearch Monitoring2018-06-29
- NAIDrug Quality Assurance2015-09-18
- NAIDrug Quality Assurance2013-09-06
- VAIDrug Quality Assurance2011-09-16
- NAIDrug Quality Assurance2009-08-14
Drugs this plant is listed as making
2 distinct drugs across 2 products name this site in their FDA label.
- amantadine hydrochlorideUpsher-Smith Laboratories, LLC
- Diclofenac PotassiumLeading Pharma, LLC
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.