Apotex Inc. - Environmental Compliance Approval (air)

This proposal is for an Environmental Compliance Approval with Limited Operational Flexibility (air) which replaces all the current Environmental Compliance Approvals for Air at this facility and includes the addition of new or historically unapproved sources for all emissions from Apotex Inc.., a pharmaceutical manufacturing facility, producing approximately 80 different pharmaceutical products, located in the City of Toronto, Ontario.

The emission sources from the manufacturing and associated processes that discharge to the air include:

• dispensing
• blending/compaction
• tabletitng
• encapsulation
• pellet process
• flaker process
• granulator processes
• storage tank and fluid bed processes

Emissions to the air from this facility include:

• nitrogen oxide
• methanol
• ethyl alcohol
• chloroform
• acetonirtile
• dichloromethane
• triethlamine
• total particulate matter

The Environmental Compliance Approval with Limited Operational Flexibility (air), when issued permits modifications to the facility subject to limits on operational flexibility that include a production limit for the facility to be specified on the Environmental Compliance Approval with Limited Operational Flexibility (air). The Limited Operational Flexibility conditions have an expiry date. The company will be required to make an application for amendment at that time to renew these conditions.