United States Food and Drug Administration (USFDA) has conducted a Pre-Approval Inspection at Lupin’s manufacturing facility located in Somerset, New Jersey, U.S.A. The Inspection was conducted from September 29, 2025 to October 10, 2025, and concluded with one observation. The company will address the observation and respond to the USFDA within the stipulated timeframe. It is committed to be compliant with CGMP standards across all its facilities.
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.
