Biocon slips after USFDA issues Form 483 with 7 observations to its sterile drug facility in Bangalore

03 May 2018 Evaluate

Biocon is currently trading at Rs. 628.60, down by 34.90 points or 5.26% from its previous closing of Rs. 663.50 on the BSE.

The scrip opened at Rs. 653.40 and has touched a high and low of Rs. 653.40 and Rs. 624.90 respectively. So far 1,72,000 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 5 has touched a 52 week high of Rs. 677.85 on 30-Apr-2018 and a 52 week low of Rs. 294.71 on 25-May-2017.

Last one week high and low of the scrip stood at Rs. 677.85 and Rs. 624.90 respectively. The current market cap of the company is Rs. 37,737.00 crore.

The promoters holding in the company stood at 60.67%, while Institutions and Non-Institutions held 20.92% and 18.41% respectively.

The US Food and Drug Administration (USFDA) has completed a pre-approval inspection of Biocon’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 USFDA with a corrective and preventive action plan in a timely manner.

Besides, the company has 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. The company will submit a corrective and preventive action plan to the European inspection agency within the stipulated time period.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.


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