Ranbaxy Lab
oratories Ltd said on Monday drug regulators in the UK and Australia had approved its manufacturing facility in north India that was earlier the target of U.S. regulatory action.
Ranbaxy, majority owned by Japan's Daiichi Sankyo, said Medicines and Healthcare products Regulatory Agency (MHRA) of the UK and Australia's Therapeutic Goods Administration issued "good manufacturing practice" certificates for the Paonta Sahib facility after a joint audit conducted last October.
The drugmaker said the MHRA approval would apply to its product filings for the entire European Union.
In February, the U.S. Food and Drug Administration halted reviews of drug applications from Paonta Sahib plant saying test results submitted in approved and pending drug applications were found to have been falsified.
Shares in Ranbaxy, whose market value has dropped more than 60 percent in the past 15 months, rose 8.2 percent to 157.20 rupees by 0651 GMT in a Mumbai market up more than 3 percent.
source : in.news.yahoo.com/137/20090323/744/tbs-ranbaxy-says-india-plant-gets-uk-aus.html
oratories Ltd said on Monday drug regulators in the UK and Australia had approved its manufacturing facility in north India that was earlier the target of U.S. regulatory action.Ranbaxy, majority owned by Japan's Daiichi Sankyo, said Medicines and Healthcare products Regulatory Agency (MHRA) of the UK and Australia's Therapeutic Goods Administration issued "good manufacturing practice" certificates for the Paonta Sahib facility after a joint audit conducted last October.
The drugmaker said the MHRA approval would apply to its product filings for the entire European Union.
In February, the U.S. Food and Drug Administration halted reviews of drug applications from Paonta Sahib plant saying test results submitted in approved and pending drug applications were found to have been falsified.
Shares in Ranbaxy, whose market value has dropped more than 60 percent in the past 15 months, rose 8.2 percent to 157.20 rupees by 0651 GMT in a Mumbai market up more than 3 percent.
source : in.news.yahoo.com/137/20090323/744/tbs-ranbaxy-says-india-plant-gets-uk-aus.html
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