United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection at Lupin’s Biotech facility located in Pune, India. The inspection was carried out from September 25, 2024 to October 4, 2024, and concluded with five observations. The company is addressing the observations comprehensively and will respond to the U.S. FDA within the stipulated timeframe.

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.