Biocon shares fall over 5% after US, European regulators issue observations
Biocon shares decline 5.53% to Rs626.80 per shares on BSE after the USFDA and a European regulator issued observations after inspection of its facility in Bengaluru
Mumbai: Shares of biotechnology major Biocon Ltd declined over 5% on Thursday after the company’s sterile drug product manufacturing facility in Bengaluru received observations from US and European regulators.
Bicon shares closed at Rs626.80 per shares on BSE, down 5.53% from its previous closing. In intraday day, the shares fell as much as 6.13% to Rs622.80. BSE Sensex closed 0.21% lower at 35,103.14 points.
The US Food and Drug Administration (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.
The company has also this week received the preliminary report from the European Regulator post inspection of its sterile drug product facility in Bengaluru in March 2018, the spokesperson added.
“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,” the spokesperson said.
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