Close Monitoring of Apotex
The Ministry of Health’s drug regulatory arm Medsafe is closely monitoring Apotex, Canada’s largest medicines
manufacturer, following the United States placing an import ban on medicines produced at two manufacturing sites by this
The United States ban was put in place after the Food and Drug Administration (FDA) found deviations from accepted
manufacturing processes at two Apotex manufacturing plants in Toronto in Canada.
In response to the FDA findings, Apotex has voluntarily recalled 40 medicines for the US market and three from the
Canadian market. None of the affected batches of recalled medicines are available in New Zealand.
Medsafe Group Manager Dr Stewart Jessamine says its Canadian regulatory equivalent Health Canada started an audit this
week of the two Canadian sites. The audit is being carefully followed by medicine regulatory authorities around the
Since last week's US import ban, Medsafe has been working with the FDA, Health Canada, PHARMAC and Apotex to determine
the implications for New Zealand products manufactured at the affected sites.
"Like many other countries, Apotex products are used in New Zealand and both agencies are working closely on the issue
to provide assurance that the public has access to affordable high quality medicines," says PHARMAC Medical Director
"Although the FDA report has raised questions about the manufacturing process at these two Canadian plants, there is no
evidence that this has led to an increased risk to patient welfare for medicines made at these plants," Dr Jessamine
said. "Our advice to patients at this time is to keep taking their medicines as prescribed."
Dr Jessamine says: "While the Health Canada audit will provide us with further information about these manufacturing
sites, given the size and complexity of the manufacturing sites the site visits themselves are likely to take up to a
"We are actively managing this emerging situation and will inform healthcare professionals and consumers if the
situation changes significantly", he said.