Apotex
Canadian generic pharmaceutical manufacturer.
Apotex develops and manufactures generic medicines, biosimilars and specialty pharmaceuticals for healthcare systems worldwide. The Toronto-based company operates manufacturing and R&D facilities serving prescription and hospital channels.
- Type
- Manufacturer
- Location
- Toronto, Canada
- Founded
- 1974
- Website
- apotex.com
- Categories
- Medical & Healthcare Supplies
- Markets
- Canada, United States, Australia, United Kingdom
Verified facts
- domain-registered (green), checked 2026-08-12 Domain registry record
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
Claimed certifications
- Good Manufacturing Practice
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)