Lupin Faces Four Observations from U.S. FDA Pre-Approval Inspection

Mumbai, September 20, 2025 – Lupin Limited has disclosed that the U.S. Food and Drug Administration (FDA) recently carried out a product-specific Pre-Approval Inspection (PAI) at the company’s Pune Biotech facility. The inspection was conducted between September 8 and September 19, 2025, and concluded with four observations. Lupin stated that it will address these observations and provide a formal response to the U.S. FDA within the stipulated timeframe. The company emphasized its ongoing commitment to complying with Current Good Manufacturing Practices (CGMP) quality standards across all manufacturing sites. This disclosure has been made under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, reaffirming transparency with stakeholders. While FDA observations are not uncommon, the market will be closely watching how swiftly Lupin resolves them, as the PAI relates to product approvals critical for the U.S. business. ✅ Disclaimer: This update is for informational purposes only and not a recommendation to buy or sell securities. 👉 Follow me for more timely corporate disclosures and financial insights.