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.
For further information:
Director of Public and Government Affairs
200 Barmac Drive
Office: 416-749-9300 Ext. 7366