Ranbaxy, Statement on FDA Letters

In response to a U.S. Food and Drug Administration press release announcing warning letters and an Import Alert for Drugs issued to Ranbaxy Laboratories Ltd. regarding drug products produced in two Ranbaxy plants in India, the company issued the following statement:

"Ranbaxy is very disappointed in the action taken by the U.S. FDA. The company has responded to each concern the FDA has raised during the past two years and had thought that progress was being made. We are, however, pleased that the FDA's testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy's drugs. The company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved. Once it has had an opportunity to review the issues, the company looks forward to continuing to cooperate with FDA to resolve the remaining issues."

According to the FDA announcement, the warning letters and Import Alert do not apply to Ranbaxy's other facilities, including its three manufacturing facilities in the U.S.: Ohm Laboratories' facilities in New Brunswick, NJ, North Brunswick, NJ, and Gloversville, NY, from which Ranbaxy delivers some 59 drug products to the U.S. healthcare system, including: Simvastatin, Acyclovir, Minocycline, Clindamycin, Lorazepam, Loratadine-D, Cetirizine, Acetaminophen Extended release tablets, Lisinopril and Zolpidem.