Biocon declines after US, European regulators issue observations

Biocon fell 5.46% to Rs 627.25 at 13:41 IST on BSE after the company's sterile drug product manufacturing facility in Bengaluru received observations from US and European regulators.

The announcement was made after market hours yesterday, 2 May 2018.

Meanwhile, the S&P BSE Sensex was down 14.90 points, or 0.04% to 35,161.52.

On the BSE, 2.04 lakh shares were traded in the counter so far compared with average daily volumes of 2.73 lakh shares in the past two weeks. The stock had hit a high of Rs 653.40 and a low of Rs 624.50 so far during the day. The stock hit a record high of Rs 677.85 on 30 April 2018. The stock hit a 52-week low of Rs 294.71 on 25 May 2017.

The US Food and Drug Administration (USFDA) completed a pre-approval inspection of the company's sterile drug product manufacturing facility in Bangalore this week and issued a Form 483 with 7 observations. The observations are largely procedural and aimed at continuous improvement. The company will respond to the FDA with a corrective and preventive action plan in a timely manner.

Further, Biocon has also received the preliminary report from the European Regulator post inspection of the company's sterile drug product facility in Bangalore in March 2018. The report lists 6 major observations with no observation classified as critical. Biocon will submit a corrective and preventive action plan to the European inspection agency within the stipulated time period.

Biocon is India's largest and fully-integrated, innovation-led biopharmaceutical company.

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