FDA stops 11 Indian-made drugs from entering U.S.

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MUMBAI, India U.S. regulators have banned 11 drugs made at an Indian drug manufacturing plant from entering the United States over safety concerns.

Last Friday, the Food and Drug Administration issued an import warning to generic drugmaker Ranbaxy Pharmaceuticals over one of its factory's in Mohali in Punjab province. The agency said Monday its inspectors uncovered multiple violations at the factory last year, including failure to investigate manufacturing problems and failure to follow quality-control standards.

Two other Ranbaxy factories are already under similar alerts from 2009.

"The FDA is committed to using the full extent of its enforcement authority to ensure that drugs made for the U.S. market meet federally mandated quality standards," Howard Sklamberg, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in a Sept 16 statement. "We want American consumers to be confident that the drugs they are taking are of the highest quality, and the FDA will continue to work to prevent potentially unsafe products from entering the country."

The FDA did not specify what was wrong with the Mohali factory or the 11 products. Ranbaxy had no immediate comment on Monday.

The news sent shares of the company's stocks plummeting.

With revenues of $2.3 billion for the last fiscal year, Ranbaxy is the leading drug maker in India's $26 billion generic pharmaceutical industry, but it has been plagued with problems in the U.S.

In May, the company's American subsidiary agreed to pay $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators, the largest financial penalty against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs.

Some of thecompany's generic drugs "lacked necessary active ingredients due to poor quality control standards into interstate commerce," according to a statement from the New York State Attorney General's office.

In late 2012, another subsidiary, Ranbaxy Pharmaceuticals Inc., was forced to halt production of a generic version of the cholesterol drug Lipitorto investigate how tiny glass particles got into the ingredients used for dozens of batches that had to be recalled. It was Ranbaxy's second recall of the drug in three months.

Ranbaxy Laboratories Ltd. stock price fell by 30.3 percent to 318.40 rupees ($5.10) by the close of trading on the Bombay Stock Exchange.

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