Lupin Limited, one of India’s leading pharmaceutical companies, announced that the U.S. Food and Drug Administration (FDA) recently conducted a product-specific Pre-Approval Inspection at its Pune Biotech facility. The inspection took place from September 8 to September 19, 2025, and concluded with four observations.
The company has confirmed that it will address these observations and respond to the U.S. FDA within the stipulated timeframe. Lupin reaffirmed its commitment to maintaining strict compliance with Current Good Manufacturing Practice (CGMP) quality standards across all its facilities.
This disclosure has been made in accordance with Regulation 30 of the SEBI Listing Regulations, ensuring transparency for investors and stakeholders.