Citing Consent Decree, Ranbaxy Withdraws Dozens of Generic Drug Registrations
Posted 22 August 2012 | By
Indian generic drug manufacturer Ranbaxy announced 22 January that the US Food and Drug Administration (FDA) has, per its request, withdrawn 27 Abbreviated New Drug Applications (ANDAs) for products as part of a Consent Decree signed in January.
The Consent Decree, more formally known as a Consent Decree of Permanent Injunction, was the end result of an investigation by FDA into data integrity deficiencies at a number of the company's India- and US-based manufacturing facilities. The company signed onto the decree in January and shortly thereafter received approval from the US Department of Justice.
Withdrawal of Products
As part of the decree, FDA said the company would be required to permanently withdraw ANDAs for products originating from its facility in Batamandi, India.
"Corporate Defendants shall withdraw all NDAs and ANDAs that contain data or other information generated or developed at Batamandi, and shall never submit another Application to FDA for any drug that is the subject of the withdrawn Batamandi NDAs and ANDAs and shall never transfer such NDAs and ANDAs to a third party," wrote DOJ in the decree.
At the time of the decree, DOJ officials said the company had, "Submitted false data in drug applications to the FDA, including the backdating of tests and the submitting of test data for which no test samples existed … making many of Ranbaxy's drugs adulterated, potentially unsafe and illegal to sell in the US."
In a 22 August statement, Ranbaxy said the products had already been discontinued-FDA has prevented products manufactured at the facility from entering the US since 2008-and would have a, "Negligible impact on the company's business."