The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the
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 today 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. These actions are proactive measures that the FDA is taking 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 has no evidence to date that Ranbaxy has shipped defective products. We will continue to monitor the situation.
Today's announcement does not impact products from Ranbaxy's other plants which are not affected by today's actions. FDA has inspected those facilities and, to date, they have met
The FDA recommends that consumers continue taking their medications manufactured by Ranbaxy and not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.
Ranbaxy is one of the largest foreign suppliers of generic drugs to the
The FDA Import Alert covers more than 30 different generic drug products 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
For a list of drugs manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd., please visit: http://www.fda.gov/cder/drug/infopage/ranbaxy/ranbaxy_list.htm
For more information, please visit:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01886.html
http://www.fda.gov/cder/drug/infopage/ranbaxy/qa.htm
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