Both facilities are cGMP compliant
Lupin announced that it has received Establishment Inspection Reports (EIR) for its Mandideep and Aurangabad facilities wherein the US FDA has concluded that the inspections stand closed.The US FDA had conducted audits at Lupin's Mandideep facility from 8th to 19th February, 2016 and its Aurangabad facility from 11 to 15 January 2016.
As stated earlier, the Company had taken appropriate steps to address the observations it had received from these audits. Having received the EIRs from the US FDA about the closure of these inspections, all observations stand addressed, and both these facilities are cGMP compliant.
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