FDA Issues Second Warning Letter to Apotex

The Food and Drug Administration has posted on their website a March 29th warning letter to Apotex, Canada’s biggest drug company citing lapses that included charred particles in a diabetes drug, contamination of an antihistamine and a drug cross-contamination that resulted from inadequate cleaning of manufacturing equipment.

The FDA letter also claims that Apotex had failed to notify regulators in a timely fashion about such problems.

This is the second warning letter by the FDA to Apotex is less than a year which is highly unusual for the agency.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing concerns by foreign pharmaceutical companies have been discovered within the supply chain that could have been detected at various points of the supply chain by readily available material authentication solutions.

The New York Times has an excellent article about this FDA letter, written by Natasha Singer and published on April 15th.

To view this article, visit: http://www.nytimes.com/2010/04/16/business/16generic.html.

To learn more about material authentication solutions, visit: http://www.xstreamsystems.net/.

Canadian Drug Maker Apotex Recalls Medications

CanWest News Service Reported September 17th that Canadian generic drug giant Apotex voluntarily recalled some of its drugs late Thursday following a Health Canada investigation launched last July into the company's manufacturing practices.

The investigation was initiated after U.S. regulators found "significant deviations" from good manufacturing practices during an inspection at Apotex's Toronto plant.

In a news release, Health Canada said Thursday the recall applies to three lots of drugs including:

• Apo-Amilzide (5 to 50 mg),
• Apo-Meloxicam (7.5 and 15 mg)
• Apo-Ranitidine (75 and 150 mg)

These medications are used to treat rheumatoid arthritis, osteoarthritis, excess stomach acid or liver cirrhosis.

Health Canada said that it will continue to inspect the Apotex facilities for the next few weeks to ensure that there is compliance.

It urges any Canadians currently taking the drugs to contact their family doctor.
The FDA warned Apotex in June that officials would begin blocking drugs at the border by the Toronto-based company if it did not begin complying with good manufacturing practices, which are universally accepted standards for product quality control.

To read the entire CanWest article visit: www.canada.com.

FDA Cracks Down on Apotex in Canada

Apotex has experienced a high number of rejected batches and FDA is cracking down on this generic brand company in Toronto. XStream endorses a comprehensive materials analysis process within the supply chain to protect end users to appropriate quality and control.

Canada's Apotex Inc could face a freeze on new drug applications in the United States as well as a ban on products entering the country after the U.S. Food and Drug Administration warned it of a number of
manufacturing breaches at a Toronto factory.

The June 25 warning, which followed a late 2008 inspection of the Etobicoke, Ontario facility, cited a number of manufacturing deviations from U.S. manufacturing codes.

Among the breaches, the agency charged that Apotex did not thoroughly investigate the failure of batches of some drugs and also noted an unusual high number of rejected batches.

To view article visit: www.reuters.com