Apotex Inc.
Overview
Apotex Inc. is a Canadian pharmaceutical company that produces a wide range of affordable and high-quality generic medications. It is a leader in research and development of innovative pharmaceutical solutions.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances Apotex Inc. is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
Apotex Inc. holds 50 active (52 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- VILOXAZINE HYDROCHLORIDEActive2024-11-07
- OLANZAPINE FORM II USPActive2022-07-28
- FLUTICASONE PROPIONATE USP (MICRONIZED)Active2020-12-30
- BREXPIPRAZOLEActive2019-03-11
- ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USPActive2018-11-02
- PALBOCICLIBActive2018-07-25
- ELIGLUSTAT TARTRATE (1:0.5)Active2018-05-01
- TOFACITINIB CITRATEActive2018-03-29
- TREPROSTINIL DIETHANOLAMINEActive2017-10-05
- TASIMELTEONActive2017-07-31
- BULK EVEROLIMUSActive2016-10-27
- POSACONAZOLEActive2016-03-31
- AXITINIBActive2015-10-10
- OLANZAPINE USPActive2015-06-22
- DEXLANSOPRAZOLE ANHYDRATEActive2015-03-30
Showing 15 of 52 Drug Master Files.
FDA compliance signals
50 FDA enforcement records linked to this company.
- recall — Class II2026-04-22
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
- recall — Class II2026-03-25
Lack of Assurance of Sterility
- warning_letter2025-10-31
FDA Warning Letter (drug product)
- recall — Class II2025-10-08
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
- recall — Class II2025-10-08
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
- recall — Class II2025-07-02
Lack of Assurance of Sterility
- recall — Class II2025-07-02
Lack of Assurance of Sterility
- recall — Class II2025-07-02
Lack of Assurance of Sterility
- recall — Class II2025-06-11
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
- 4832025-05-09
Complaint Handling Procedure
- 4832025-05-09
Equipment to control conditions
- 4832025-05-09
Procedures for sterile drug products
- 4832025-05-09
Cleaning / Sanitizing / Maintenance
- 4832025-05-09
Following/documenting laboratory controls
- 4832025-05-09
Computer control of master formula records
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