By IANS,
New Delhi : Ranbaxy Laboratories Thursday said it had retained the services of former New York City mayor Rudy Giuliani to extend advice on the US regulator’s decision to ban some 30 medicines produced at its two Indian plants.
Giuliani and his firm Giuliani Partners will advice and review the compliance issues related to the recent United States Food and Drug Administration (FDA) letters and import advisory, the company said in a statement.
“As the FDA stated, all drugs manufactured by Ranbaxy have repeatedly tested safe and effective with no adverse incidents reported,” the company said.
“Ranbaxy is committed to a swift resolution to address these issues and to continuing to supply the global marketplace with safe and effective pharmaceuticals.”
The US regulatory authority has said Tuesday that it was blocking the sale of some of Ranbaxy’s drugs including the popular antibiotic Cipro and cholesterol pill Zocor, in view of manufacturing deficiencies at the company’s two India units – at Dewas and Paonta Sahib.
The blocked drugs include the antibiotics ciprofloxacin and clarithromycin, the antiviral acyclovir, cholesterol-lowering simvastatin and pravastatin, and the diabetes drug metformin.
The two FDA warning letters, which listed the concerns over the deviations from US current good manufacturing practice requirements and suggested the problems at two suspect plants, relate to deficiencies in the company’s drug manufacturing process.
The announcement had a major impact on the company’s scrip as in 2007, north America remained the largest market for Ranbaxy with a 26-percent share, contributing to sales worth $419 million. Europe was next with $365 million.