MUMBAI, April 3 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. (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.
($1 = 1.1038 Canadian dollars)
(Reporting by Zeba Siddiqui; Editing by Matt Driskill)