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Apotex Working to Get FDA Import Alert Against Two Toronto Plants Lifted

Thu, 09/10/2009 - 4:42am
TORONTO — Apotex Inc., the largest Canadian-owned pharmaceutical company, says it is working with U.S. regulators to correct problems at two of its plants in Toronto. The U.S. Food and Drug Administration has issued an import alert banning products from Apotex plants in North York and Etobicoke. Issued Aug. 28, the alert calls for "the detention without physical examination of all finished form drug products imported to the U.S. from these facilities," according to an FDA email in response to questions from The Canadian Press. Apotex said Wednesday that the alert relates to "observations made following routine audits for products destined to the U.S. only." "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," Jack Kay, Apotex president and chief operating officer, said in statement. Apotex, founded in 1974, employs over 6,500 people in research, development, manufacturing and distribution facilities world wide. Some 5,800 of the employees work at the Canadian operations in Ontario, Quebec, Manitoba, Alberta and British Columbia.

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