Lupin gets 4 observations from USFDA from PAI at Pune Biotech facility

The U.S. FDA has conducted a product-specific Pre-Approval Inspection (PAI) at the Company's Pune Biotech facility from September 08 to September 19, 2025. The inspection closed with four observations.

We will address the observations and respond to the U.S. FDA within the stipulated timeframe. We are committed to be compliant with CGMP quality standards across all our facilities.

Shares of Lupin Limited was last trading in BSE at Rs. 2056.20 as compared to the previous close of Rs. 2046.00. The total number of shares traded during the day was 10066 in over 1104 trades.

The stock hit an intraday high of Rs. 2061.00 and intraday low of 2041.00. The net turnover during the day was Rs. 20664663.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals ProductSpecific PreApprovalInspection Pune BiotechFacility USFDA 4Observations