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Manufacturing facility

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 β€” so if this plant has a problem, these are the products that could be affected.

Country
Canada
Registered address
50 Steinway Blvd., Etobicoke, Ontario M9W 6Y3, Canada (CAN)
Operations here
analysismanufacture
FDA identifiers
FEI 3002808376 Β· DUNS 205576023

FDA inspection history

Outcomes of closed FDA inspections at this site (drug and biologic program areas).

  • NAIBioresearch Monitoring2024-09-27
  • NAIDrug Quality Assurance2024-02-23
  • NAIDrug Quality Assurance2019-11-08
  • VAIDrug Quality Assurance2019-07-12
  • NAIDrug Quality Assurance2017-12-08
  • NAIDrug Quality Assurance2016-05-27
  • NAIDrug Quality Assurance2013-09-13
  • VAIDrug Quality Assurance2011-02-11
  • OAIDrug Quality Assurance2008-12-19

Drugs this plant is listed as making

10 distinct drugs across 20 products name this site in their FDA label.

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.

Apotex Inc. β€” facility profile Β· DrugDashboards