United States Food and Drug Administration (USFDA) has completed inspection at Lupin’s Somerset, New Jersey, U.S.A. manufacturing facility. USFDA inspected the said facility from January 2, 2023 to January 13, 2023. The inspection closed with issuance of a Form-483 with two observations. The company is addressing the observations comprehensively and will work with the USFDA to resolve these issues at the earliest. The company upholds quality and compliance with utmost importance and 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.
