India's biggest drugmaker Ranbaxy Laboratories, which is under the scanner of USFDA, has said it would file on Monday its response denying allegations of systemic fraudulent conduct motion by US Department of Justice.
"Ranbaxy strongly denies allegations contained in the motion that has been filed (not granted) by the US Department of Justice seeking certain documents," the company said in a statement.
The company said the US Food and Drugs Administrator (USFDA) has gathered over 200 random samples of various products marketed by it the US.
These products have been independently tested by the USFDA and were found to be complying with all the specifications, it added.
"Under these circumstances the company finds that the allegations are baseless."
A response would be filed on Monday in US court to defend the company against the motion filed by US Department of Justice, it said.
The company's business in the US continues as normal and it also clarifies that the company's deal with Daiichi Sankyo is binding and final and remains on track, it added.
Meanwhile Daiichi Daiichi Sankyo officials asserted the deal with Ranbaxy for acquiring majority stake in Gurgaon -based company remained intact.
"We are aware of the fact that US FDA has filed a motion against Ranbaxy and the development would not affect the deal with the company for acquiring majority stake in the company," Daiichi Sankyo spokerperson said while refusing to comment further on the issue.
Earlier, US Department of Justice has made number of allegations against the company while filing a motion against the company.
The US Department of Justice has alleged that Ranbaxy submitted false and fabricated information to the USFDA.
The US government said "allegations from reliable sources and supporting documents indicate a pattern of systemic fraudulent conduct, including submissions by Ranbaxy to the FDA."
It further said the submissions contained false and fabricated information about stability and bioequivalence of drugs, failure to timely report the distribution of drugs that were out of specifications, and attempts to conceal violations of good manufacturing practise (GMP) regulations from FDA. Also it alleged fabrication of bioequivalence and stability data by Ranbaxy to support abbreviated new drug applications (ANDA) filed with FDA for generic drugs to be distributed in the United States, and also for anti-retroviral drugs (ARV) paid by the President's Emergency Plan for Aids Relief (PEPFAR) programme.
"Ranbaxy has used active pharmaceutical ingredients (API) from unapproved sources and has blended unapproved API with approved API and in some case it has used lesser API in its drug that had been approved by FDA," it added.
The department has also accused the Ranbaxy of using tactics to delay the proceedings.
US health regulator said, after notifying Ranbaxy's management, the FDA has conducted an inspection of the company's drug product manufacturing facility in Poanta Sahib on February 2006 and the inspection has revealed significant deviation GMP regulations.
After that on November 29, 2006 Ranbaxy executives met FDA representatives to present a status update and describe the quality improvement program.
On February 14, 2007, federal agents executed search warrants at Ranbaxy facilities in New Jersey and seized documents and imaged computers.
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