Lupin has received the Establishment Inspection Report (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 inspection was conducted at company’s global pharmacovigilance group DSRM (Drug Safety & Risk Management) based out of Mumbai between January 14, 2019 and January 18, 2019. 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.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.