Biocon’s Insulin Manufacturing Facility In Malaysia Gets 3 Obsevations From U.S. FDA (PAI) Inspection

The U.S. Food and Drug Administration (FDA) conducted a pre-approval inspection (PAI) of Biocon Ltd’s subsidiary, Biocon Sdn. Bhd’s Insulins manufacturing facility based in Malaysia, for Insulin Glargine, between Feb 10 and Feb 21, 2020.

At the conclusion of the inspection, the agency issued a Form 483 with 3 observations which the company believes are procedural in nature.

The company will respond to the FDA with an appropriate Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. The FDA has set a Target action date for our Insulin Glargine application in June 2020. The company believes that the outcome of this inspection does not in any way impact the commercialization plans of insulin glargine in the US. Biocon Biologics is committed to global standards of Quality and Compliance.

Shares of BIOCON LTD. was last trading in BSE at Rs.315 as compared to the previous close of Rs. 306.05. The total number of shares traded during the day was 230972 in over 3518 trades.

The stock hit an intraday high of Rs. 319.05 and intraday low of 305. The net turnover during the day was Rs. 72696192.-Equity Bulls