Apotex

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Apotex, Inc.
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
Revenue more then C $1 billion (in world wide sales)[2]
Employees 6,800 (2012)[3]
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.[3] The company produces more than 300 generic pharmaceuticals in approximately 4000 dosages, and 600 molecules under development. Apotex exports products to over 115 countries around the globe.[3]There are more prescriptions filled with Apotex products in Canada than that of any other pharmaceutical company.

Structure[edit]

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 February 2014, Emergent BioSolutions, an American company based in Rockville, Maryland, acquired Cangene Corporation. [4]

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. [3]

Bernard (Barry) Sherman is the chairman and CEO and Jack M. Kay is the President.[1]

Philanthropy[edit]

Apotex founded the Apotex Foundation, a privately held charitable organization, which has donated over $17 million in medicines over the last 10 years. Critical medicines have been shipped to every disaster zone around the globe to provide assistance to humans in need. Apotex was also the only Canadian company to develop and manufacture a combination drug for AIDS patients in Rwanda.

Problems with regulator[edit]

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.[5] It also received a warning letter citing similar GMP violations in the Signet plant on March 29, 2010. [6] 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.[6] The import ban was subsequently lifted on May 6, 2011.[7] 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’.[8]

FDA inspected the same plants again in 2013 and issued warning letters for more problems. [9] In April 2014, FDA banned a manufacturing plant owned by Apotex in Bangalore, India. In the warning letter, FDA indicated that the plant routinely deleted failed test results and replaced with retest results that passed. FDA found that the violations are systemic and were dated back for many years, having the same issues noted in past inspections since 2006.[9]

Lawsuits[edit]

On 17 May 2013, a group of pregnant Canadian women filed a class-action lawsuit against Apotex, after it was discovered that the company's recalled birth control pill packages contained more placebos than usual. [10]

References[edit]

  1. ^ a b "SEC Info - Sherman Bernard C, et al. - SC 13D - Counsel Corp - On 12/29/03". Retrieved 2009-02-17. 
  2. ^ http://www.apotex.com/global/about/
  3. ^ a b c d "Apotex Corporation Information". Retrieved March 21, 2012. 
  4. ^ Press Release (21 February 2014). "Emergent BioSolutiions Completes Acquisition of Cangene Corporation". Emgergent Biosolutions. Retrieved 17 June 2014. 
  5. ^ FDA (June 25, 2009). "Warning Letter". Retrieved March 21, 2012. 
  6. ^ a b FDA (March 29, 2010). "Warning Letter". Retrieved March 21, 2012. 
  7. ^ Silverman, Ed (May 20, 2011). "Apotex creeps out of the FDA dog house". Pharmalot.com. Retrieved March 21, 2012. 
  8. ^ Palmer, Eric (March 19, 2012). "Apotex says FDA import ban, delays ‘decimated’ its business". fiercepharmamanufacturing.com. Retrieved March 21, 2012. 
  9. ^ a b Palmer, Eric (17 June 2014). "FDA says Apotex India plant has faked data for years". fiercepharmamanufacturing.com. Retrieved 17 June 2014. 
  10. ^ Palmer, Eric (20 May 2013). "Women want Apotex to pay for unwanted pregnancies". fiercepharma.com. Retrieved 17 June 2014. 

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