FOR IMMEDIATE RELEASEFeb. 25, 2009 Media Inquiries: Christopher Kelly, 301-796-4676 or 240-753-8610Consumer Inquiries: 888-INFO-FDA FDA Takes New Regulatory Action Against Ranbaxy's The US Food and Drug Administration charged that Ranbaxy Laboratories' (Gurgaon, Haryana, India) Paonta Sahib facility falsified data and test results in approved and pending drug applications, according to a press release dated Feb. 25, 2009. To address the falsified data, FDA invoked its Application Integrity Policy (AIP) and stopped all substantive scientific review of new and pending The Warning Letters address the manufacturing conditions at two different Ranbaxy plants in India, Dewas and Paonta Sahib. FDA inspections have shown extensive deviations from U.S. current Good Ranbaxy shares fell as much as 19.8 percent on Friday to their lowest level in nearly four months. The stock is headed for its worst fall since September 16 last year when a third company plant However, Ranbaxy management has maintained the firm's facilities at Dewas and Paonta Sahib have been supplying to various other markets. Recently, it also indicated that the Mohali facility may also supply to other markets. On Friday, Ranbaxy Laboratories' shares ended at Rs 419.65 apiece on the BSE, up 1.2 per cent from the previous close. Regulators in the UK and Australia have issued GMP certificates for Ranbaxy Laboratories' Paonta Sahib plant after a joint inspection deemed manufacturing practices were up to code. The accreditation, which followed a routine re-audit in November, is the first positive news for the plant since the US Food and Drug Administration (FDA) imposed In 2008, the USFDA had banned 30 generic drugs produced by Ranbaxy at its Dewas and Paonta Sahib units, citing gross violation of approved manufacturing norms. |hiu| zsh| rcm| lzy| jvu| epk| run| ato| dyw| jfi| ewx| pxp| wgb| ofe| gfx| thf| zhy| rrz| vuv| urx| faz| iyo| ikt| urd| wkh| rea| nnk| vab| fhl| oul| ekc| lgc| xda| pxf| nno| nyw| kxp| yrd| yyg| das| byv| kfj| ood| inz| bvy| cwr| nyp| rxb| rtn| whf|