FDA Issues Two Warning Letters, Import Alert to Drug Plants in India

The U.S. Food and Drug Administration recently announced it has issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.

The Warning Letters identify the agency's concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit) in India. Because of the extent and nature of the violations, FDA issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API)--the primary therapeutic component of a finished drug product--and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process. FDA said these actions are proactive measures taken in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA said it has no evidence to date that Ranbaxy has shipped defective products and will continue to monitor the situation.

This action does not impact products from Ranbaxy's other plants. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.

The FDA Import Alert covers more than 30 different generic drug products (Drug List) produced in multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two locations. FDA has evaluated whether these actions would create any potential drug shortages in the United States, and has determined that other suppliers can meet market demand, with one exception. Because Ranbaxy is the sole supplier to the U.S. of one drug product, Ganciclovir oral capsules (an antiviral drug), to avoid creating a shortage of the drug, FDA generally will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues.

This represents the second time in less than three years FDA has issued a Warning Letter to Ranbaxy. In 2006, FDA cited Ranbaxy for violations of U.S. cGMP at its Paonta Sahib facility.

For more information, go to www.fda.gov/medwatch/report.htm.

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