OTTAWA, Sept. 24, 2014 /CNW/ - At Health Canada's request, Apotex Inc. will quarantine products for the Canadian market manufactured at the Apotex Research Private Limited (ARPL) facility in Bangalore, India, based on a recent import ban of products from that facility by the U.S. Food and Drug Administration (FDA).
Health Canada is gathering more information, including the reasons for the FDA's actions and the potential impact of any issues it has identified on products for the Canadian market. The quarantine will allow the Department time to verify that products from this facility meet Canadian safety and quality requirements.
A quarantine means the company will stop distribution of products in its possession. At this time, neither Health Canada nor the FDA has requested a recall of any products from the ARPL facility. The Department will continue to keep Canadians informed as further information becomes available.
Health Canada last inspected the ARPL facility in February 2014 with an international regulatory partner. The visit resulted in a compliant rating. The FDA had issued a compliant rating to the same facility following its own inspection in 2013.
Drug production is a global business, and Health Canada works with its international regulatory partners to monitor the manufacturing practices used to make the medicines that Canadians take. Health Canada continues to work with the FDA, other trusted international regulatory partners and the company to gather more information about the situation at the Apotex ARPL facility and the products affected.
Health Canada will work with the provinces and territories to monitor the supply situation and, if necessary, develop mitigation strategies.
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SOURCE: Health Canada
For further information: Media Inquiries: Health Canada, (613) 957-2983; Public Inquiries: (613) 957-29911-866 225-0709