Apotex sees Health Canada lift ban on two India plants

Canadian generics maker Apotex has seen Health Canada conditionally lift a ban against two of the company's manufacturing units in India after noting corrective work in progress has passed a threshold, the Toronto Star reports.

Apotex's Bangalore, India, plant

In September last year, drugs and APIs from the two plants in the southern Indian city of Bangalore were placed under an import ban in Canada and the United States after inspectors from the U.S. FDA found evidence that drug sample testing was flawed. Products from the plant remain banned in the U.S.

Late last year, FDA inspectors found that employees had deleted data of failed test results and then reported that the batches had passed, a practice Apotex had received warnings about during inspections dating back 8 years.

However, Health Canada visited both plants in June and found "satisfactory progress" to fix faults, according to Toronto Star.

"Health Canada concluded that the corrective work implemented has progressed to a point where products from these facilities may now be imported on the Canadian market under specified conditions," the regulator said in an announcement quietly posted to its website on Sept. 1, cited by the Toronto Star.

Still, the Toronto Star said, the lifting of the ban comes with the conditions that staff at Apotex's Canadian labs must retest all of the products from the two Indian plants before they can be released to market. The company has said it already employed that condition before the ban, according to the Toronto Star.

The Toronto Star noted, however, that Apotex, Canada's largest drug company, is slated to appear in Canadian federal court to contest the earlier ban.

"The minister's decision to implement the import ban was politically motivated and, in particular, was calculated to deflect public and parliamentary criticism of the minister as a result of the Toronto Star articles," Apotex alleged in its court filing, cited by the Toronto Star.

An Apotex spokesman declined to comment to the Toronto Star.

In May, Apotex recalled more than 35,000 bottles of generic Zyprexa, an antipsychotic, that were manufactured at a plant in Toronto that was recently nicked by the FDA for a number of issues.

- here's the story from the Toronto Star

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