FDA bans imports from Canadian drugmaker Apotex's India plant

MUMBAI Thu Apr 3, 2014 12:47pm IST

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MUMBAI (Reuters) - The U.S. Food and Drug Administration banned imports from Canadian drugmaker Apotex Inc's manufacturing plant in India for not complying with quality standards, the latest in a series of sanctions against medicines produced in India.

Drugs made at the plant, based in Bangalore, will be detained without physical examination because the factory did not meet the FDA's good manufacturing practices, the agency said on its website on Wednesday.

The ban excludes Riluzole, a drug used to treat amyotrophic lateral sclerosis, commonly called Lou Gehrig's disease. (r.reuters.com/pug23v)

The ban on Apotex's factory comes after manufacturing plants of top Indian drugmakers like Ranbaxy Laboratories Ltd (RANB.NS), Wockhardt Ltd (WCKH.NS) and Sun Pharmaceutical Industries Ltd (SUN.NS) were barred from exporting to the United States due to quality concerns.

The FDA has stepped up scrutiny of medicines made in India, which supplies about 40 percent of generic and over-the-counter drugs to the United States.

FDA Commissioner Margaret Hamburg in February said the agency was not unduly targeting drug companies in India, but "undertaking our required regulatory activities" needed to protect public health in the United States.

Apotex currently makes about 260 generic drugs, or copies of name-brand pharmaceutical products, that are sold in Canada and exported to more than 115 countries. The company's sales exceed C$1 billion a year, according to its website.

Ontario-based Apotex was not available to comment outside of regular business hours and calls to its Bangalore research facility went unanswered.

(Reporting by Zeba Siddiqui; Editing by Matt Driskill)

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