Shares in Ranbaxy Laboratories slumped 18 per cent on Thursday after US regulators said a plant owned by the drugmaker had falsified data.
The US Food and Drug Administration (FDA) said it halted reviews of drug applications from Ranbaxys Paonta Sahib plant in India after test results submitted in approved and pending drug applications were found to have been falsified.
The action applies to about 25 approved drug applications that contain data from the plant,an official of the agency said. It indicates that more drugs produced from Paonta Sahib will be put under review. It might have an incremental (negative) impact on Ranbaxy, said Sarabjit Kour,an analyst with Angel Broking. Ranbaxy shares ended the day down 18 per cent at Rs 169.95,in a Mumbai market that rose 0.6 per cent. Last September,the FDA had banned more than 30 generic drugs from entering the US that were made at Ranbaxy plants in Paonta Sahib and Dewas in India. These included cholesterol-lowering drugs,AIDS medications and antibiotics. Paonta Sahib and Dewas together account for 30-40 per cent of Ranbaxys US sales,Kour estimated. The drugmaker gets about a quarter of its sales from the US. FDA officials said they had not identified any health risks from Ranbaxy drugs on the market yet.
Meanwhile,FDA has said it might seek third-party audit for drug applications from Paonta Sahib plant. To address the falsified data,the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility, it said. Under AIP,the regulator may implement a Corrective Action Operating Plan ,which FDA said,might include seeking a third-party independent audit of drug applications associated with the plant.