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Facility profile

Apotex Inc.

Testing & analysis · Drug product manufacturing · Ontario M9W 6Y3 · Canada

FDA recordFDA directory updated Jul 22, 2026Profile not yet claimed11 registered company locations
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

AnalysisManufacture
Due diligence

Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 22, 2026

Latest matched inspection
No action indicated (NAI)

Sep 27, 2024 · No conditions warranted FDA action in this inspection.

Matched compliance actions
Past action on file · 2009

More than five years old · review later records.

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Shows

Registration status and a latest matched no action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history9 inspection records

FDA inspection history

9 records, Dec 2008 – Sep 2024 · 6 NAI · 2 VAI · 1 OAI

DateClassProject areaCitationsFY
Sep 27, 2024NAIBioresearch Monitoring2024
Feb 23, 2024NAIDrug Quality Assurance2024
Nov 8, 2019NAIDrug Quality Assurance2020
Jul 12, 2019VAIDrug Quality Assurance2019
Dec 8, 2017NAIDrug Quality Assurance2018
May 27, 2016NAIDrug Quality Assurance2016
Sep 13, 2013NAIDrug Quality Assurance2013
Feb 11, 2011VAIDrug Quality Assurance2011
Dec 19, 2008OAIDrug Quality Assurance2009

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Jun 25, 2009Warning Letter · CDER
Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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