USFDA has classified the inspection conducted at Lupin’s Goa facility from January 28 to February 8, 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 inspection at the Goa facility had closed with two observations. Based on USFDA's Concept of Operations program, the Company understands that the status of the facility is still under review.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.