The US Food and Drug Administration (USFDA) has concluded a Pre Approval Inspection at Lupin’s Somerset, New Jersey manufacturing facility. The inspection was conducted from May 7, 2024 to May 17, 2024, and closed with an issuance of a Form-483 with six observations. The company is addressing the observations comprehensively and will respond to the USFDA 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.
