Ranbaxy Laboratories has denied allegations of fraudulent misconduct made by the US Department of Justice.
Evidence collected in a two-and-a-half-year investigation by the US Food and Drug Administration suggested Ranbaxy may have misrepresented the quality of medicines and chemicals it exported to the US.
US federal prosecutors in July claimed Ranbaxy’s “violations have resulted and continue to result” in the importation of adulterated and misbranded medications. US regulators inspected Ranbaxy plants in India, Uganda and Nigeria and subpoenaed company records while the FBI raided the company’s offices in Plainsboro, New Jersey, and a plant in New Brunswick, New Jersey.
“Except for the issues that have already been fully aired with the government, Ranbaxy knows of no evidence to support these allegations,” the company said while filing its response before the District Court of Maryland. The company, represented by law firm London & Mead, said it would cooperate with the FDA.
In its eight-page response, the company also said that US authorities had not shared details of their concerns despite repeated requests, adding that this “is entirely consistent with the Department of Justice’s ordinary practice in investigations”.
The investigation of Ranbaxy, which in July triggered a probe by the US Congress, is the latest in a growing list of high-profile cases that have shaken confidence in the FDA’s ability to root out unsafe medicines while renewing concerns over the quality of low-cost generic drugs, the StarLedger of New Jersey reported.
