The inspection by the the USFDA for facility at Nagpur was carried out between August 5, 2019 and August 8, 2019. It closed without any 483 observations.
Homegrown pharma major Lupin Ltd on August 8 said the US health regulator has completed inspection at its Nagpur oral solid manufacturing facility.
The inspection by the the US Food and Drug Administration (USFDA) for facility at Nagpur was carried out between August 5, 2019 and August 8, 2019. It closed without any 483 observations, Lupin said in a statement.
Commenting on the outcome of the inspection, Lupin Managing Director Nilesh Gupta said, "We are committed to adherence and full compliance with cGMP (current good manufacturing practice) regulations at all our manufacturing sites".
He further said, "The Nagpur facility is our latest oral solid dosage facility and this was the sixth USFDA inspection at the facility. We are very happy that the inspection closed with no 483s".
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