Ranbaxy Responds to US Investigation

November 20, 2008
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Ranbaxy Laboratories (Gurgaon, Haryana, India) responded to an investigation of violations at two of its manufacturing plants, according to a Reuters Health report.

New Delhi (Nov. 17)-Ranbaxy Laboratories (Gurgaon, Haryana, India) responded to an investigation of violations at two of its manufacturing plants, according to a Reuters Health report. Malvinder Singh, Ranbaxy’s chief executive officer, told journalists at the India Economic Summit that the company expects an early resolution, the report said.

The US Department of Justice (DOJ) is investigating whether Ranbaxy violated federal law, and the probe includes allegations of conspiracy, false statements, and healthcare fraud. DOJ seeks to determine whether Ranbaxy fabricated bioequivalence and stability data to support abbreviated new drug applications and whether the company attempted to conceal violations of current good manufacturing practice (CGMP).

On Sep. 16, 2008, the US Food and Drug Administration issued an Import Alert for generic drugs produced at Ranbaxy’s Dewas and Paonta Sahib, India, plants. The Alert allowed US officials to prevent more than 30 generic drugs from entering the country because of CGMP violations at the facilities. The Alert affected finished products such as amoxicillin, metformin HCl, and ranitidine.

In response to the Alert and two Warning Letters about the manufacturing plants, Ranbaxy hired Rudy Giuliani and Giuliani Partners to provide advice and review compliance issues. The company pledged to cooperate with FDA and take measures to ensure that the products affected by the Alert could reenter the US market.

See Ranbaxy's statement about the Warning Letters.