(Photo: Hemant Mishra/ Mint)
(Photo: Hemant Mishra/ Mint)

Lupin gets four observations from USFDA

  • Lupin has received the EIR from the USFDA for the post-marketing adverse drug experience inspection
  • The inspection was conducted at its global pharmacovigilance group DSRM based out of Mumbai between 14-18 January, 2019

NEW DELHI : Drug firm Lupin on Tuesday said it has received four observations in the establishment inspection report (EIR) given by the US health regulator following the closure of pharmacovigilance inspection.

"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.

Lupin 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 14-18 January, 2019, Lupin said.

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

Shares of Lupin Ltd were trading 0.18% higher at 802.80 apiece on BSE.

This story has been published from a wire agency feed without modifications to the text.

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