The USFDA announced that Ranbaxy has falsified data and results in approved and pending drug application filed from the Paonta Sahib facility in India.
Hence, the Regulator has invoked Application Integrity Policy (AIP) halting approval of new drugs from the Paonta Sahib facility.
The AIP is invoked when a company’s actions raise significant questions about the integrity of data in drug applications. This AIP covers applications that rely on data generated by the Paonta Sahib facility only.
However, the Regulator has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.
Earlier, on September 16, 2008, the FDA issued two warning letters and instituted an Import Alert barring entry of all finished drug products and active pharmaceutical ingredients from Ranbaxy’s Dewas, Paonta Sahib and Batamandi Unit facilities due to violations of US current Good Manufacturing Practices requirements.
That action barred commercial importation of 30 different generic drugs into the US and remains in effect. We await further clarity from Management on the issue. We maintain a BUY on the stock.