Biocon dips 4% on seven USFDA observations for Bengaluru drug facility

Shares of Biocon have dipped 4% to Rs 634 per share on the BSE in early morning trade on Thursday after the biotechnology major on Wednesday said that US health regulator has made seven observations after inspection of its sterile drug product manufacturing facility in Bengaluru this week.

"The US Food and Drug Administration (US-FDA) has completed a pre-approval inspection of our sterile drug product manufacturing facility in Bangalore this week and issued a Form 483 with 7 observations,” Biocon said in a filing to BSE.

“The observations are largely procedural and aimed at continuous improvement. We will respond to the FDA with a corrective and preventive action plan in a timely manner,” it added.

Also, the company this week received the preliminary report from the European Regulator post inspection of its sterile drug product facility in Bangalore in March 2018.

The report lists 6 major observations with no observation classified as critical. We will submit a corrective and preventive action plan to the European inspection agency within the stipulated time period,” a Biocon spokesperson said.

At 09:25 am; the stock was trading at Rs 639, down 3.6% as compared to 0.06% decline in the S&P BSE Sensex. A combined 473,464 shares changed hands on the counter on the BSE and NSE so far.