Citing concerns about drug quality, the Food and Drug Administration on Monday announced a ban on imports of any products made at the generic drug maker Ranbaxy’s newest factory in India.
The move is the third time Ranbaxy imports have been blocked in the United States since 2008.
The factory in Mohali, in the Punjab region of India, is not currently producing any products sold in the United States, according to the Food and Drug Administration.
But the recently renovated facility was to be the centerpiece of Ranbaxy’s comeback from years of major manufacturing lapses, so the news that it, too, would now be prohibited from making drugs destined for the United States sent investors fleeing on Monday.
Ranbaxy’s stock fell by 30 percent, to 318.5 rupees ($4.99), in Mumbai on Monday and financial analysts predicted the development could slow the introduction of several products, including the generic version of the best-selling blood pressure drug Diovan, which has already been delayed for a year. Ranbaxy is a subsidiary of the Japanese pharmaceutical company Daiichi Sankyo.
The F.D.A. said it decided to issue the ban after agency inspectors uncovered significant manufacturing violations at the Mohali facility in September and December of last year. It said the company would be required to hire an outside expert to inspect the Mohali factory and certify that it met the agency’s standards before the restrictions were lifted.
A spokesman for Ranbaxy declined to comment on Monday. Ranbaxy officials have said they are awaiting further details from the F.D.A.
Ranbaxy has been operating under a federal consent decree with the F.D.A. since last year. In May, the company pleaded guilty to federal drug safety violations as part of a $500 million settlement that was the largest in history involving a generic manufacturer and drug safety. As part of the settlement, Ranbaxy admitted that it had failed to conduct proper safety and quality tests of drugs made at its Indian plants. Two other Ranbaxy plants have been operating under an import ban since 2008.
In spring 2012, Ranbaxy began exporting generic Lipitor to the United States that was manufactured at Mohali, a facility the company said in a news release at the time was “equipped with the latest state-of-the-art technology.” But late last year, the company halted all production of generic Lipitor after tiny pieces of glass were found in the tablets. When sales resumed in March, the drug was being manufactured at the company’s Ohm Laboratories facility in New Jersey.
Despite the Lipitor setback, some investors had held out hope that the company would make a comeback by selling exclusive copies of best-selling drugs, many of them manufactured at the Mohali facility.
Several analysts speculated that the F.D.A’s action could further delay the debut of generic Diovan, a hypertension drug by Novartis that lost its patent protection one year ago. Ranbaxy has the exclusive right to sell the generic version of the drug for six months, but the F.D.A. has not given final approval. A competing generic company, Mylan, unsuccessfully sued the F.D.A. last year to force the agency to revoke Ranbaxy’s exclusive rights.
Ranbaxy and the F.D.A. have not said where generic Diovan would be manufactured, but the analysts Nitin Agarwal and Param Desai of IDFC Securities in India said in a note Monday that the ban on the Mohali plant was likely to put further pressure on Ohm Laboratories, which they said was now Ranbaxy’s only manufacturing plant selling products to the United States market. “The facility is already running at full capacity,” they wrote in the note, in which they also downgraded the stock to underperform. “The alert on Mohali facility will hurt future approvals.”
Article source: http://www.nytimes.com/2013/09/17/business/us-bans-import-of-ranbaxy-drug-made-in-india.html?partner=rss&emc=rss