In late August, the U.S. Food and Drug Administration (FDA) issued an import alert for two of Apotex Inc.’s Canadian facilities. The alert means that products from those two sites can be stopped at the American border.
In a warning letter, the FDA revealed that an inspection at one of the factories in question “revealed significant deviations from U.S. current good manufacturing practice regulations.”
Rwanda has a soon-to-expire contract with Apotex for 15.6 million Apo-TriAvir tablets, according to a company document. The first shipment of 6.8 million pills arrived last September, while the second shipment of 8.8 million tablets is scheduled to arrive in Kigali early next week.
Mr. Elie Betito, Apotex’s director of public and government affairs, said the Apo-TriAvir pill was inspected and approved by Canadian Health Ministry, which serves as that country’s drug regulator.
“The FDA alert has nothing to do with this product,” Betito said in an e-mail late Thursday night.
In a statement, Apotex also stressed the American concerns were specifically in regard to drugs destined for the United States, and the company was working to resolve the issue.
Following the U.S. alert, other countries have announced their own reviews of Apotex.
In a statement this week, Canada’s Health Ministry said it was inspecting Apotex plants in the city of Toronto, as well as working with Apotex on a “thorough review” of the company’s manufacturing practices.
Apotex also issued a voluntary recall for three drugs as a precautionary measure, Health Canada said.
In New Zealand, the national health safety authority imposed a temporary restriction on importing Apotex products, due to the concerns raised by the FDA.
Mr. Eric Nyiligira, acting director general for the Rwanda national drug distributor CAMERWA, said he was not told about the FDA alert when he recently spoke to an Apotex official about the Apo-TriAvir shipment.
However, he said he would look into the matter.
“If an audit found that some standards were not met, that is the cause of some worry,” Nyiligira previously told RNA.
Apo-TriAvir is also the focus of a national study being undertaken by TRAC Plus, Rwanda’s national centre for infectious disease control and prevention.
TRAC Plus launched the study in late July after some patients reported skipping their doses because the tablets have a bitter taste.