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US FDA says Ranbaxy falsified drug application data
There seems to be no relief for Ranbaxy as US Food and Drug Administration (FDA) said it will not review drug applications from Ranbaxy's Paonta Sahib plant. That the company's facility has falsified some drug application and test data and it is still being investigated to ensure safety and efficacy of marketed drugs.
There seems to be no relief for Ranbaxy as the US Food and Drug Administration (FDA) said it will not review drug applications from Ranbaxy's Paonta Sahib plant. FDA said the company's facility has falsified some drug application and test data and it is still being investigated to ensure safety and efficacy of marketed drugs. It has asked Ranbaxy to cooperate to resolve questions of data integrity and reliability.
The US FDA, however, said it has not identified any health risks associated with company's currently marketed products and urged patients not to stop taking Ranbaxy drugs. Concerned patients should talk to doctors, it said.
Ranbaxy's action
When contacted, Ranbaxy said all the Abbreviated New Drug Applications (ANDAs) from Paonta Sahib facility are added to the list under American Institute of Physics (AIP). "We will continue to cooperate with the US FDA," it said.
According to the US FDA, Ranbaxy has the option of withdrawing any effective applications or subjecting them to a validity assessment to assure the FDA of the integrity of the data contained in the applications.
