Biocon Tanks 4% On Account Of USFDA Observations On Malaysian Unit

The Indian biopharmaceutical company Biocon saw its stocks tumble by as high as 4.58 per cent to Rs 251.90 per scrip on Monday as of 11:04 IST on the Bombay Stock Exchange (BSE) compared to the previous close of Rs 262 on Friday. 

On Friday, Biocon in an exchange filing revealed that the USFDA had conducted two inspections at its Insulins Manufacturing Facility in Malaysia between July 10 and July 20, 2023. 

"The U.S. Food and Drug Administration (FDA) conducted two cGMP inspections at Biocon Sdn. Bhd’s Insulins Manufacturing Facility in Malaysia, encompassing Biologics Drug Substance, Drug Product units and Quality Control laboratories, as well as the Delivery Devices unit," the company said in a statement. 

Biocon said that the agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories as well as 2 observations for the Delivery Devices unit.

These observations primarily relate to enhancing operational procedures and strengthening training programs. The inspections did not identify any data integrity breaches or systemic non-compliance, the company said.

"We will submit a Corrective and Preventive Action (CAPA) plan to the U.S. FDA in a timely manner and are confident of addressing these observations expeditiously. Biocon Biologics remains committed to global standards of Quality and Compliance,” Biocon stated.