NAFTA Tribunal Decision Supports FDA and Its Actions

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Aug 26, 2014, 08:30 ET

TORONTO, Aug. 26, 2014 /PRNewswire/ - Apotex Inc., the largest Canadian owned pharmaceutical company, announced today that an arbitration tribunal rejected Apotex's claims that the FDA violated NAFTA by prohibiting imports of Apotex products from two plants in Ontario, Canada.

"The FDA's import alert against our Etobicoke and Signet facilities effectively removed Apotex from the US solid-dose drug market for almost two years," said Dr. Jeremy B. Desai, Apotex's President and Chief Executive Officer. "While we are disappointed in the Tribunal's decision, we remain strongly committed to the U.S. market and we continue to work closely with the FDA to resolve all outstanding issues and to achieve our shared objective of expanding the public's access to quality, affordable generic medicines."

Apotex is the largest Canadian owned pharmaceutical company with over 5,500 employees. Globally it has another approximately 4,500 employees with estimated sales of approximately $2 billion.

With its worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year.

It produces 300 medicines in 4,000 dosages and formats that are exported to 115 countries.

It has 500 products under development and will spend $2 billion over the next 10 years on research and development. With an aging population, the global healthcare systems have a strong need for affordable quality medicines.

The US State Department posts documents in the NAFTA arbitration to its website, at http://www.state.gov/s/l/c50826.htm. The NAFTA tribunal's decision will be posted to this webpage after it has been reviewed to remove confidential commercial information.

SOURCE Apotex Inc.