* Action stems from FDA’s June 25 warning letter
* Says drugs affected include versions of diltiazem
By Scott Anderson
TORONTO, Sept 8 (Reuters) - Apotex Inc faces a ban on products entering the United States after the U.S. Food and Drug Administration warned the Canadian drugmaker about a number of manufacturing breaches at a Toronto factory, according to an industry analyst.
The action, which affects new product, follows a June 25 warning letter and a late 2008 inspection of the Etobicoke facility, which cited a number of deviations from U.S. manufacturing codes.
Neither the privately held generic drugmaker, which is a significant supplier to the U.S. market, nor the FDA immediately responded to requests for comment.
“We have learned that on Friday an import ban was placed on Apotex products manufactured in Canada...” Adam Greene, an analyst at RBC Capital Markets in New York, wrote in a note.
“While details are still limited, it is our understanding that products already in inventory in the U.S. can be shipped to customers but new product cannot be shipped to the U.S. until the ban has been lifted.”
Greene said most of the products affected appear to be older items with fairly low pricing and “ample competition”, including Apotex’s generic versions of diltiazem, used to treat high blood pressure and angina.
Among the breaches cited in the June 25 letter, the FDA charged that Apotex did not thoroughly investigate the failure of batches of some drugs and also noted an unusually high number of rejected batches.
This, the FDA suggested at the time, “demonstrates a lack of adequate process controls and raises significant concerns regarding the capability and reliability of (Apotex‘s) processes to consistently manufacture drug products meeting predetermined specifications.”
The FDA also said the company, which is Canada’s biggest drugmaker, failed to meet the required timeframe for alerting the agency about significant chemical or physical changes in distributed drugs.
The FDA warned in the June letter that the company could face an import ban and said it would also “recommend withholding approval of any new applications or supplements listing your firm as a drug product manufacturer.”
The action comes as the FDA continues to crack down on manufacturing breaches among generic drug companies.
Earlier this year, U.S. authorities seized all products made by generic drugmaker Caraco Pharmaceutical Laboratories Ltd CPD.A following repeated violations of manufacturing standards. The company was warned about manufacturing problems in an FDA letter sent in October 2008.
$1=$1.08 Canadian Reporting by Scott Anderson; editing by Rob Wilson