Biocon shares decline over 6%; mcap plunges Rs 1,896.95 crore

New Delhi: Shares of Biocon Ltd fell over 6 per cent on Wednesday after the company said the US health regulator has classified as "official action indicated" for the manufacturing facility of group firm Biocon Sdn Bhd at Johor, Malaysia following an inspection.

The stock fell 6.21 per cent to settle at Rs 238.55 on the BSE. During the day, it declined 6.91 per cent to Rs 236.75.

At the NSE, it fell 6.17 per cent to end at Rs 239.15.

The company's market valuation tumbled Rs 1,896.95 crore to Rs 28,640.31 crore.

In traded volume terms, 3.39 lakh shares of the firm were traded at the BSE and over 1.30 crore shares at the NSE during the day.

The OAI (official action indicated) status may cause delay and/or withholding of pending product approvals or supplements from the facility, Biocon Ltd said in a regulatory filing on Wednesday.

"Biocon Sdn Bhd, a step-down subsidiary of Biocon Biologics Ltd, has received a communication from the US Food and Drug Administration (FDA) pursuant to its July 2023 CGMP inspection at its insulins manufacturing facility at Johor, Malaysia," a company spokesperson said in the filing.

The USFDA has "determined the inspection classification as 'OAI'. The OAI status may cause delay and/or withholding of pending product approvals or supplements from the facility", the spokesperson added.

As per the USFDA, OAI implies that the regulator may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance of manufacturing norms laid down by it.

The spokesperson said the company has submitted a Comprehensive Corrective and Preventive Action (CAPA) plan to the USFDA in response to observations from the July inspection and believe it is on track to complete all actions as committed.