Biocon share price: The Biocon stock fell as much as almost three percent during the session, after the company said the EDQM categorised one deficiency found at its Bengaluru API plant as 'major’.
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Biocon shares were under pressure on Friday, after the European Directorate for the Quality of Medicines and Healthcare — a body that sets quality and ethical standards for drugs in Europe — issued a list of deficiencies at the Indian company's plant in Bengaluru.
The Biocon stock fell by as much as Rs 9.4 or 3.2 percent to Rs 281.9 apiece on BSE after the news.
There were no critical deficiencies, and one deficiency was categorised as 'major’, Biocon said in a regulatory filing on Thursday. The biotech pharma company also said it will be responding to the agency's observations within stipulated time.
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The European agency had conducted a good manufacturing practices inspection at Biocon's API site in Bengaluru from September 12 to September 14, according to the filing.
"Biocon remains committed to the quality, safety and efficacy of its products," it added. The observations by the European agency follow inspections by the US Food and Drug Administration (FDA), after which the US drug regulator issued Form 483s with 17 observations for the company's sites in Bengaluru and Malaysia.
"We do not expect the outcome of these inspections to impact the current supply of our products. Biocon Biologics remains committed to global standards of Quality and Compliance," a company spokesperson had said.
Biocon shares have lost more than six percent of their value in the past one month, a period in which the Nifty50 benchmark has declined 2.2 percent.
Indian equity benchmarks Sensex and Nifty slipped into the red amid choppy trade after a flat start on Friday, dragged by financial, FMCG and IT shares.
First Published: Oct 7, 2022 1:36 PM IST