"The U.S. FDA conducted a Pre-Approval Inspection (PAI) at two of our new Biologics Manufacturing facilities in Bengaluru from Sep 10 to Sep 19, 2019. The inspection included a new Drug Substance (DS) and a Drug Product (DP) unit.
At the conclusion of the inspection we received a Form 483 with four observations for the new DS facility, three observations for the new DP facility and one general observation. We are confident of addressing these observations effectively through a Corrective and Preventive Action (CAPA) plan, expeditiously. The Pre-Approval Inspection of our new facilities does not have any impact on our current commercialization plans from our existing facilities." - Company Spokesperson.
Shares of BIOCON LTD. was last trading in BSE at Rs.228 as compared to the previous close of Rs. 227.3. The total number of shares traded during the day was 187880 in over 1943 trades.
The stock hit an intraday high of Rs. 232.8 and intraday low of 223.55. The net turnover during the day was Rs. 42923297.