Ranbaxy hires New York ex-mayor Giuliani to resolve issues with US FDA
18 Sep 2008
Mumbai: Ranbaxy Laboratories Ltd has hired former New York city mayor Rudolph Giuliani and Giuliani Partners to provide advice and review compliance issues related to the recent United States Food and Drug Administration letters and Import Advisory, the company said in a press release.
The move comes a day after the US FDA banned the import of around 30 generic drugs produced by the drug firm at its plants in Dewas and Paonta Sahib in India citing manufacturing deficiencies.
On Tuesday, the FDA barred Ranbaxy from importing 30 of its drugs, including generic versions of the popular antibiotic Cipro and the cholesterol pill Zocor, manufactured at its Indian factories, citing poor quality.
The FDA yesterday issued two warning letters to Ranbaxy claiming procedural violations at its plants in Dewas and Paonta Sahib in India.
The US regulators said they would not approve more drugs manufactured at the two plants until their concerns were met.
The FDA, however, had stated that all drugs manufactured by Ranbaxy have repeatedly tested safe and effective with no adverse incidents reported.
Ranbaxy, one of the world's largest manufacturers of generic drugs with production facilities in the United States and India, said it is committed to work closely with the FDA to address the Import Advisory and put into place measures which will allow its products identified on the advisory to be released into the US marketplace.
Generic drug sales in the US accounted for 23 per cent of Ranbaxy's total revenue last year.
