The United States Food and Drug Administration (USFDA) has classified the inspection conducted at Lupin's Pithampur (Indore) Unit-2 facility in January 2019 as Official Action Indicated (OAI). The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed.
The company does not believe that this classification will have an impact on disruption of supplies or the existing revenues from operations of this facility.
The company is in the process of sending further updates of its corrective actions to the USFDA and is hopeful of a positive outcome.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.
