BUSINESS

FDA import ban: R'bxy hires ex-NY Mayor as advisor

Source:PTI
September 18, 2008

Ranbaxy Laboratories has hired former New York Mayor Rudolph Giuliani as an advisor after the US blocked imports of 30 of its generic drugs citing manufacturing deficiencies.

The US Food and Drug Administration has issued two warning letters to Ranbaxy claiming procedural violations at its plants in Dewas and Paonta Sahib in India.

Giuliani, a high-profile Republican leader and former US attorney in Manhattan, would provide advice and review compliance issues. Ranbaxy has been accused of selling generic drugs which did not meet FDA standards.

The regulators said they would not approve more drugs manufactured at the two plants until their concerns were met and the firm said it would try to swiftly resolve the issues.

The regulators alleged that the company used raw chemicals from unapproved sources and fabricated data to meet FDA standards.

Giuliani, whose popularity skyrocketed for effective handling of the situation after the September 11, 2001 terrorist strike on the World Trade Center, had unsuccessfully sought the Republican presidential nomination this year which was ultimately clinched by John McCain.

Announcing the appointment of Giuliani, Ranbaxy affirmed its commitment to work cooperatively with FDA to address the issues and put into place measures which will allow its products to be released in the US market.

The company noted that FDA has stated that all drugs manufactured by it have repeatedly tested safe and effective with no adverse incidents reported.

"Ranbaxy is committed to a swift resolution to address these issues and to continuing to supply the global marketplace with safe and effective pharmaceuticals," it said.

Source: PTI
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