Lupin Ltd has received a letter from the U.S. FDA classifying the inspection conducted at the Company's Mandideep (Unit 1) facility in December 2018 as 'Official Action Indicated' (OAI). The U.S. FDA 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.
There are no new DMF and ANDA applications pending review or approval from the Mandideep (Unit 1) facility and 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 U.S. FDA and remains hopeful of a positive outcome.
Shares of LUPIN LTD. was last trading in BSE at Rs.763.9 as compared to the previous close of Rs. 800.85. The total number of shares traded during the day was 214168 in over 5256 trades.
The stock hit an intraday high of Rs. 805.4 and intraday low of 758. The net turnover during the day was Rs. 165781489.