Apotex 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
- 380 Elgin Mills Road East, Richmond Hill, Ontario L4C 5H2, Canada (CAN)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3001617666 · DUNS 255092496
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 3 drugs. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2025-05-09
- NAIDrug Quality Assurance2024-03-08
- NAIBioresearch Monitoring2023-03-24
- VAIDrug Quality Assurance2022-09-14
- NAIDrug Quality Assurance2019-06-28
- NAIBioresearch Monitoring2019-03-22
- VAIDrug Quality Assurance2017-04-11
- NAIDrug Quality Assurance2015-03-04
- VAIDrug Quality Assurance2013-08-30
- OAIDrug Quality Assurance2012-10-26
- VAIDrug Quality Assurance2010-08-17
Drugs this plant is listed as making
3 distinct drugs across 4 products name this site in their FDA label.
- DasatinibApotex Corp.
- memantine hydrochlorideApotex Corp.
- moxifloxacinGolden State Medical Supply, 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.