Biocon falls nearly 6% on USFDA observations for Bengaluru facility

Shares of Biocon today tumbled nearly 6 per cent after the biotechnology major said the US health regulator had made seven observations after inspection of its sterile drug product manufacturing facility in Bengaluru.

The stock ended the day at Rs 626.80, a loss of 5.53 per cent on BSE. Intra-day, it fell 6.13 per cent to Rs 622.80.

On NSE, shares of the company shed 5.56 per cent to end at Rs 627.

Following the drop in the stock price, the company's market valuation went down by Rs 2,202 crore to Rs 37,608 crore.

In terms of equity volume, 2.61 lakh shares of the company were traded on BSE and over 30 lakh shares changed hands on NSE during the day.

The observations are largely procedural and aimed at continuous improvement, Biocon said in a filing to BSE yesterday.

The USFDA has completed pre-approval inspection of the sterile drug product manufacturing facility in Bengaluru this week and issued a Form 483 with 7 observations, the filing said.

"We will respond to the USFDA with a corrective and preventive action plan in a timely manner," a Biocon spokesperson said.

An FDA Form 483 is issued to firm management at the conclusion of an inspection by the USFDA. It notifies the company's management of objectionable conditions at the facility.