Tuesday, September 15, 2009

Canadian drug maker facing ban on U.S. exports

From the Globe and Mail:
Canada's largest drug manufacturer is facing a ban on some of its exports to the United States after an inspection of its factory revealed what the United States Food and Drug Administration considers “significant deviation” from its manufacturing guidelines.

The FDA has issued an Import Alert for Toronto-based Apotex Inc., which produced 300 generic drugs that fill 85 million prescriptions each year worldwide.

It only affects products destined for the U.S.

“We are actively working with the FDA to resolve the identified concerns as quickly as possible, and are optimistic that there will be a prompt resolution,” Apotex said in a statement.

In a June 25 warning letter, the FDA said inspections of the company's Etobicoke facility showed several deviations from U.S. manufacturing codes. The agency alleged Apotex didn't thoroughly investigate the failure of batches. ...more

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