Apotex faces import ban by American regulators

FDA threatening to restrict drugs produced at two Toronto plants

Unsanitary lab conditions, defective drugs that made the U.S. market, and a lack of “corrective actions” led the U.S. Food and Drug Administration to threaten an import ban on drugs produced at two Toronto-area plants.

The U.S. regulator issued a warning letter in February to Apotex, Canada’s largest manufacturer of generic drugs, citing “repeated deficiencies” at Apotex’s Toronto and Richmond Hill locations.

Health Canada, however, says the recent issues investigators found at the Apotex plants have no impact on quality control of products destined for Canadian markets.

Apotex told the Star the lab that tested positive for unsanitary conditions because of microbial growth was never intended to produce drugs for commercial use.

“Those citations actually were attributed to a product that we’ve actually never commercialized and put into the marketplace — in any market,” said Jeremy Desai, Apotex president and CEO. Neither Desai, the FDA nor Health Canada would say which drugs were involved at either facility. The FDA declined to comment.

Jean Saint Pierre, manager with Health Canada Inspectorate, says the agency has been on site twice since the warning was issued in February 2013, and will be back in May and October for “full fledged” inspections.

He said the U.S. warnings were “strictly about products that are for the American market.”

In 2009, Apotex was subject to an import ban in the U.S. for similar conditions, says the February 2013 warning. Desai says his company spent $30 million upgrading their facilities, which include the Toronto and Richmond Hill plants, as well as one in Etobicoke and another in India.

The ban is the subject of a lawsuit between Apotex and the U.S. government with the drug giant seeking $520 million (U.S.) in damages for lost profits. The import ban was lifted in July 2011. Apotex dropped from the sixth-largest drug manufacture by volume, to the 25th, according to The Canadian Press.

Court filings by Apotex say their business was “decimated” and that U.S. investors received more “favourable” treatment from the FDA.

Desai said Apotex has responded to the February 2013 warning letter from the FDA, and is awaiting the regulator’s response.