Health Canada Lifts Restrictions on Two Apotex Indian Mfg Facilities

Health Canada, the regulatory body of Canada, has said that corrective work implemented at Apotex Pharmachem India Pvt. Ltd. (APIPL) and Apotex Research Private Limited (ARPL) in India has progressed to a point where products from these facilities may now be imported to the Canadian market under specified conditions.

Health Canada had take action in September 2014 to restrict products coming to Canada from APIPL and ARPL in India due to unsatisfactory processes and systems.In June 2015, Health Canada inspectors conducted a verification of the corrective measures implemented by Apotex. Apotex's actions included the implementation of new computer systems, strengthened operating processes and procedures, as well as training and re-training of staff.

Health Canada has now concluded that the corrective work implemented has progressed to a point where products from these facilities may now be imported on the Canadian market under specified conditions. As such, Health Canada has amended the company's license to include the following conditions as the company ramps up production at the two Indian sites and completes outstanding actions. Health Canada requires that product originating from APIPL and ARPL be re-tested at an Apotex good manufacturing practices-compliant facility in Canada before entering the Canadian market, and Health Canada requires Apotex to report any deficient testing results and investigations with products originating from these two Indian sites.

These conditions will remain in effect until Health Canada is satisfied that corrective actions are fully and sustainably implemented at both Indian sites at full production. Health Canada plans to re-inspect both Indian sites in early 2016.

As part of Health Canada's ongoing activities, Health Canada inspectors will be present in Apotex's Canadian facility beginning in September to conduct an inspection of the operations and the testing of the products from India. In addition, Health Canada requires Apotex Inc. to provide regular updates on all corrective actions implemented at APIPL and ARPL. Health Canada will continue to work with its international regulatory partners to review any new information regarding the quality or safety of products originating from APIPL and ARPL.

Source: Health Canada

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