FDA Issues Import Alert for Generic Drugs from Ranbaxy

by VR Sreeraman on Sep 17 2008 12:03 PM

 FDA Issues Import Alert for Generic Drugs from Ranbaxy
The US Food and Drug Administration Tuesday said it would block the import of more than 30 generic drugs made by Indian pharmaceutical company Ranbaxy, saying the company had failed to meet manufacturing standards.
Due to extensive violations of US requirements, the FDA issued the import alert for drugs manufactured at two Ranbaxy factories in Dewas and Paonta Sahib, the agency said in a statement.

The FDA said the move would not create any shortages as other firms could supply the needed drugs.

One exception was Ganciclovir oral capsules, an antiviral drug, and Ranbaxy as the sole supplier will be allowed to ship the drug to the United States while US officials carry out special oversight to ensure manufacturing problems are addressed, the FDA said.

"With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality," said Janet Woodstock, director of the FDA's Center for Drug Evaluation and Research.

The FDA also issued warning letters to the company citing "concerns" that Ranbaxy -- one of the main suppliers of generic drugs in the US market -- displayed "deficiencies in the company's drug manufacturing process."

One letter focused on problems at the firm's Dewas facility while a second letter addressed problems at the Paonta Sahib site.

The FDA did not plan to remove drugs already on the market, because it "has not evidence to date that Ranbaxy has shipped defective products," the agency said.

The FDA's move also did not affect products from Ranbaxy's other drug manufacturing plants.

The measures were taken "in order to assure that all drugs that reach the American public are manufactured according to" US manufacturing standards, the agency said.


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