FDA pharmaceutical import alert
TORONTO, Sept. 8 /PRNewswire/ - Apotex today issued the following statement concerning an Import Alert issued by the US Food and Drug Administration:
The Import Alert recently posted by FDA applies to products manufactured at 2 of Apotex's many facilities. This alert relates to observations made following routine audits for products destined to the US only. 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.
"We pride ourselves on being a leading maker of top-quality generic pharmaceuticals," said Jack Kay, 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."
SOURCE Apotex Inc.