FDA Sets Import Alert on Some Ranbaxy Generic Drugs

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Sept. 16, 2008 — The FDA today slapped an import alert on generic drugsmade at two plants in India run by Ranbaxy Laboratories Ltd. of India.

But the FDA recommends that consumers keep taking their Ranbaxy drugs.

“To date, we have seen no evidence of harm to consumers from drugsproduced at these two facilities and have no reason to believe that drugsalready in the U.S. from these plants pose a safety problem,” DouglasThrockmorton, MD, deputy director of the FDA’s Center for Drug Evaluation andResearch, said today at a news conference.

The import alert focuses on manufacturing practices at two Ranbaxyfacilities — one in Dewas, India, and the other in Paonta Sahib, India. Theproblems, summed up in two FDA warning letters issued today, include inadequatesterile processing operations and inadequate written records of the cleaningand use of major equipment. 

Even so, FDA officials say they haven’t found any problems with Ranbaxydrugs made at those facilities. Ranbaxy’s other drug-making facilities aren’tpart of the import alert.

Ranbaxy is one of the largest foreign suppliers of generic drugs to the U.S.The FDA’s import alert covers more than 30 different genetic drugs. A full list of those drugs is posted on the FDA’s web site.

One Ranbaxy drug, ganciclovir oral capsules (an antiviral drug), is exemptfrom the import alert because Ranbaxy is its sole supplier to the U.S. The FDAis asking Ranbaxy to take extra steps to make sure ganciclovir oral capsulesmeet the FDA’s standards.

The FDA doesn’t expect the import alert to result in any drug shortagesbecause except for ganciclovir, there are other drugmakers that can meet theneed for those drugs in the U.S., notes Throckmorton.

This is the second time in less than three years that the FDA hasissued a warning letter to Ranbaxy. In 2006, the FDA cited Ranbaxy forviolations of good manufacturing practices at Ranbaxy’s Paonta Sahib, Indiafacility.

 

Ranbaxy Responds

In a statement emailed to WebMD, Ranbaxy says it is “verydisappointed” in the FDA’s action. Ranbaxy says it “has respondedto each concern FDA has raised during the past two years and had thoughtthat progress was being made. We are, however, pleased that FDA’s testing andreview led the agency to conclude that there is no reason question the safetyor effectiveness of Ranbaxy’s drugs.”

Ranbaxy says it “looks forward to continuing to cooperate withFDA to resolve the remaining issues” at the two Indian plantsnoted in the import alert. Ranbaxy also confirms that the company’s otherfacilities, three of which are in the U.S., aren’t subject to the FDA’s warningletters.

 

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