[April 03, 2014]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 the southern
Indian city of 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. (http://r.reuters.com/pug23v)
The ban on Apotex's factory comes after manufacturing plants of top
Indian drugmakers like Ranbaxy Laboratories Ltd, Wockhardt Ltd and
Sun Pharmaceutical Industries Ltd 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 ($906 million) 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)
