The U.S. Food and Drug Administration (US-FDA) conducted an on-site preapproval inspection (PAI) of our Malaysian subsidiary Biocon Sdn. Bhd's manufacturing facility for Insulin Aspart between Sep 13 and Sep 24, 2021.
At the conclusion of the inspection, the agency has issued a Form 483 with a total of 6 observations across Drug Substance, Drug Product and Devices Facilities.
"We are confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan (CAPA), which will be submitted to the US FDA in the stipulated time. We do not expect the outcome of this inspection to impact our commercialization plans for insulin Aspart in the US. Biocon Biologics remains committed to global standards of Quality and Compliance." - Company Spokesperson.
Shares of Biocon Ltd. was last trading in BSE at Rs. 360.2 as compared to the previous close of Rs. 367.8. The total number of shares traded during the day was 58311 in over 1281 trades.
The stock hit an intraday high of Rs. 370 and intraday low of 358.1. The net turnover during the day was Rs. 21084987.