PRESS STATEMENT FDA PHARMACEUTICAL WARNING LETTER
TORONTO – Apotex Inc. today issued the following statement concerning a Warning Letter issued by the US Food and Drug Administration on Feb 21st, 2013:
The Warning Letter posted today by FDA applied to products manufactured at two of Apotex's Canadian facilities. It relates to observations made following routine cGMP audits from August 2012 and October 2012. We are actively working with the FDA to resolve the identified concerns as quickly as possible, and are optimistic that there will be a prompt resolution. In addition, we are actively working with Health Canada very closely to assure alignment with our
local health authority's expectations.
"We pride ourselves on being a leading maker of top-quality generic pharmaceuticals," said Dr. Jeremy Desai, President and COO of Apotex. "Since 1974, Apotex has produced approximately 200 billion tablets and capsules. These safe and effective products are sold in over 115 countries."
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