TORONTO, Sept. 26, 2014 /CNW/ - Apotex Statement: There has been a great deal of confusion regarding two of our facilities in Bangalore, India. We need to set the record straight.
Apotex has two manufacturing facilities located in Bangalore, India. One manufactures raw materials (APIPL), and the other, finished products (ARPL). Both facilities have been inspected by Health Canada, as well as one other major international regulatory agency this year, and have been given a Compliant rating.
“When raw materials or finished products are imported into Canada, they must undergo a rigorous retesting process at a Canadian facility before being distributed to the Canadian market. This secondary testing is not an option, but a legal mandate for all pharmaceutical companies shipping products and materials into Canada that provides an added level of precaution before the product reaches pharmacy shelves. This allows Health Canada to remain confident in the safety and effectiveness of imported products, and subsequently avoid any significant disruption in supply for patients.” stated Dr. Jeremy Desai, Apotex President and CEO.
It is also important to note that although that mandate requires confirmatory testing on at least one lot per year, per dosage, Apotex goes above and beyond this requirement and retests every lot of finished product supplied to the Canadian market. For that reason, Apotex is absolutely confident in the safety and effectiveness of all of our products throughout the entirety of our manufacturing and testing processes, regardless of where it was manufactured.
Apotex is fully committed to working with regulators to provide every assurance necessary to maintain a steady supply of quality products to our customers and patients in all markets.
SOURCE Apotex Inc.
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