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.
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
Investigations of discrepancies, failures
- 4832025-05-09
Equipment to control conditions
- 4832025-05-09
Written in-process control procedures
- 4832025-05-09
Complaint Handling Procedure
- 4832025-05-09
Cleaning / Sanitizing / Maintenance
- 4832025-05-09
Following/documenting laboratory controls
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