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.
- Bupropion HydrochlorideBluePoint Laboratories
- desmopressin acetatein shortageBluePoint Laboratories
- Eslicarbazepine AcetateApotex Corp.
- EtodolacMedsource Pharmaceuticals
- Ibandronate SodiumGolden State Medical Supply, Inc.
- Selegiline HydrochlorideApotex Corp.
- TasimelteonApotex Corp.
- tizanidineApotex Corp.
- Tizanidine HydrochlorideApotex Corp.
- Triamterene and HydrochlorothiazideBluePoint Laboratories
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.