Biocon shares tank 6% on USFDA observations

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Shares of Biocon tumbled 6 percent today as the biotechnology major said the US health regulator had made seven observations after inspecting its sterile drug product manufacturing facility in Bengaluru.

The stock plunged 5.81 per cent to Rs 624.90 on the BSE. On the NSE, shares of the company dropped 5.97 percent to Rs 624.30.

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

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 filing said that 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.

A Biocon spokesperson said that “We will respond to the USFDA with a corrective and preventive action plan in a timely manner”.

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


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