Apotex
 | |
| Company type | Private |
|---|---|
| Industry | Health Care |
| Founded | 1974 |
| Headquarters | Weston, Ontario, Canada |
Key people | Dr. Bernard Sherman, CEO Jack M. Kay, President [1] |
| Products | Generic Pharmaceuticals |
Number of employees | 6,800 (2012)[2] |
| Website | www.apotex.com |
Apotex is a Canadian pharmaceutical corporation. Founded in 1974, the company is the largest producer of generic drugs in Canada, with sales exceeding $1 billion (CAD) a year.[2] The company produces more than 300 generic pharmaceuticals in approximately 4000 dosages, exporting to over 115 countries around the globe.[2]
The company has two main divisions: medical research and development; and biotechnology. The biotechnology division is divided into three subsidiaries.
Apotex owns 61% of Cangene Corp., a Winnipeg-based biopharmaceutical company, according to Cangene's 2007 annual report. Cangene's business focuses are hyperimmunes, contract manufacturing, biopharmaceuticals and biodefense against infectious diseases such as smallpox, hepatitis B and anthrax. Its products include WinRho SDF.
In 1991, Apotex opened Apotex Fermentation in Winnipeg to develop fermentation-based technologies for the production of Active Pharmaceutical Ingredients (APIs) and to manufacture APIs for eventual sale as final dosage forms in Canada and internationally. The factory employs 150 people.
In January 2004, ApoPharma was founded. It is the subsidiary responsible for research and development of new chemical entities. [2]
Bernard (Barry) Sherman is the chairman and CEO and Jack M. Kay is the President.[1]
Apotex received a warning letter from the U.S. Food and Drug Administration (FDA) regarding the Etobicoke plant on June 25, 2009 for good manufacturing practice (GMP) violations.[3] It also received a warning letter citing similar GMP violations in the Signet plant on March 29, 2010. [4] FDA issued an import ban on all drugs manufactured at these two plants and prevented the company from seeking new marketing authorizations in the U.S on August 28, 2009.[4] The import ban was subsequently lifted on May 6, 2011.[5] On February 29, 2012, Apotex filed a claim to the International Centre for Settlement of Investment Disputes seeking arbitration with the U.S.A. In the filing, Apotex cited unfair treatment by FDA which constituted a violation of the North American Free Trade Agreement (NAFTA). Apotex further claimed that the action of FDA ‘decimated its business’.[6]
In 2013, a group of pregnant Canadian women filed a class-action lawsuit Friday against Apotex, after it was discovered that the company's recalled birth control pill packages contained mostly placebos.[7]
References
- ^ a b "SEC Info - Sherman Bernard C, et al. - SC 13D - Counsel Corp - On 12/29/03". Retrieved 2009-02-17.
- ^ a b c d "Apotex Corporation Information". Retrieved March 21, 2012.
- ^ FDA (June 25, 2009). "Warning Letter". Retrieved March 21, 2012.
- ^ a b FDA (March 29, 2010). "Warning Letter". Retrieved March 21, 2012.
- ^ Silverman, Ed (May 20, 2011). "Apotex creeps out of the FDA dog house". Pharmalot.com. Retrieved March 21, 2012.
- ^ Palmer, Eric (March 19, 2012). "Apotex says FDA import ban, delays 'decimated' its business". fiercepharmamanufacturing.com. Retrieved March 21, 2012.
- ^ Pregnant Canadian women sue over faulty birth control pills