You are here: Home » Companies » News
Business Standard

Lupin gets four observations from USFDA for pharmacovigilance inspection

USFDA issues an EIR to an establishment that is the subject of an FDA or FDA-contracted inspection following the closure of the inspection

Press Trust of India  |  New Delhi 

Lupin
Lupin

Drug firm on Tuesday said it has received four observations in the (EIR) given by the US health regulator following the closure of

"The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin's marketed products worldwide. The inspection closed with four observations," the company said in a regulatory filing.

has received the EIR from the United States Food and Drug Administration (USFDA) for the post-marketing adverse drug experience (PADE) inspection, indicating successful closure of the inspection, the filing added.

The inspection was conducted at its global pharmacovigilance group DSRM (Drug Safety & Risk Management) based out of Mumbai between January 14-18, 2019, said.

The issues an EIR to an establishment that is the subject of an FDA or FDA-contracted inspection following the closure of the inspection.

Ltd were trading 0.18 per cent higher at Rs 802.80 apiece on BSE.

First Published: Tue, May 14 2019. 11:45 IST
RECOMMENDED FOR YOU