United States Food and Drug Administration (USFDA) has concluded prior-approval inspection at Lupin’s Biotech manufacturing facility in Pune, India in October 2022. The inspection concluded with the issuance of a Form 483 with seventeen observations. The Company does not believe that the 483 letter will have an impact on the existing revenues from operations of this facility.
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.