Lupin has informed that the U.S. FDA has conducted a product-specific Pre-Approval Inspection at the Company’s Pune Biotech facility from September 08 to September 19, 2025. The inspection closed with four observations. The company will address the observations and respond to the U.S. FDA within the stipulated timeframe. The company is committed to be compliant with CGMP quality standards across all its facilities.
The above information is a part of company’s filings submitted to BSE.