Lupin gets EIR for its PADE inspection

Lupin Limited has announced that it has received the Establishment Inspection Report (EIR) from the USFDA for the Post marketing Adverse Drug Experience (PADE) inspection, indicating successful closure of the inspection.

The inspection was conducted at Lupin’s global pharmacovigilance group DSRM (Drug Safety & Risk Management) based out of Mumbai between January 14 to 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.

Last week, the company had launched Clobazam tablets, 10 mg and 20 mg after getting the USFDA approval. It is being used to treat seizures associated with Lennox-Gastaut Syndrome (LGS) in patients of two years of age or older.

Also, it has received tentative approval from the USFDA for its Fosaprepitant injection 150 mg single dose viral for prevention of acute and delayed nausea and vomiting caused by the chemotherapy treatment.

On Tuesday, Lupin opened with a gap-down at Rs 785.10 from its previous close of Rs 801.35. During the day, it was up by 2.02 per cent making intra-day high of Rs 817.50.