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For Poor Manufacturing Practices, Indian Pharma Company Gets ‘Warning Letter’ From US FDA

-TheWire.in The US drug regulator says Lupin Limited's response to tackling Genotoxic impurities was not adequate. New Delhi: The US Food and Drug Administration (FDA) has sent a warning letter to the Indian pharmaceutical company Lupin Limited after deeming its efforts to address violations of various good manufacturing practices at its facility in Tarapur, Maharashtra “inadequate”. The FDA sends a ‘warning letter’ to a manufacturer if it has “significantly violated” the agency’s regulations....

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