TORONTO, Oct. 1, 2014 /CNW/ - Apotex Inc. learned yesterday of Health Canada's action to temporarily suspend, as a precautionary measure, the importation of drug products from certain plants in India including two Apotex affiliates, Apotex Pharmachem India Pvt Ltd (APIPL) and Apotex Research Private Ltd (ARPL).
Apotex believes that Health Canada's intentions in this regard are unwarranted and that, upon careful review of all of the facts, Health Canada will be fully satisfied as to the integrity and quality of all Apotex products imported from the Indian facilities.
Apotex notes that many of the raw materials that are purported to be covered by the Health Canada notice are not, in fact, manufactured at APIPL facility but, rather, are manufactured in Canada, by Apotex, in Brantford, Ontario.
Without exception, Apotex fully tests every raw material and finished product imported from its Indian sites, in satisfaction of all applicable standards, before releasing any goods for sale in Canada.
The ARPL and APIPL facilities were recently inspected and given clearance by Health Canada and another international regulatory agency in February and August 2014 and were found to be compliant. Apotex has not been made aware of any new information which would cast doubt on Health Canada's own findings.
Apotex has requested an immediate meeting with Health Canada to address any concerns that may have led to yesterday's announcement.
Apotex is confident that Health Canada will remove any import restrictions on its products from the two Indian sites.
SOURCE: Apotex Inc.
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