Apotex has run into lots of regulatory issues with the FDA over the years, but now it is regulators in the U.K. that are expressing concern. And it comes at an uncertain time for Canada’s largest drugmaker after founder and chairman Barry Sherman and his wife, Honey, were found strangled to death in their Toronto home last month.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has pulled the manufacturing certificate for an Apotex solid-dose plant in Bangalore, India, saying investigators found a risk for cross-contamination during a November inspection.
EU countries share inspections information, and the MHRA recommended that each member country consider recalling products in which cross-contamination cannot be ruled out. It said that it will issue a new certificate which would allow the plant to continue to sell products in the EU if Apotex gets a written agreement with member countries and there is a danger of shortages of critical drugs.
Apotex has a long history of quality problems uncovered by the FDA. Apotex had products from plants in Toronto and Quebec banned from 2009 to 2011. After the ban was lifted in 2011, Apotex filed suit through the North American Free Trade Act, alleging the FDA action was unwarranted and decimated its business, costing it $500 million in lost sales and expenses. The international authorities sided with the FDA. On a return inspection to the plants in 2013, the FDA found more issues and again issued warning letters. (more...)
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