Shares of biopharma major Biocon extended their losing streak for the fifth straight session on Wednesday and fell over 2% in intraday trade on the Bombay Stock Exchange. The largecap stock has lost 12% in the last five trading days, compared to 1% decline in BSE benchmark Sensex, after the Kiran Mazumdar Shaw-led company received a major deficiency alert for its active pharmaceutical ingredient (API) plant located in Bengaluru.

Biocon shares trade lower than 5-day, 20-day, 50-day, 100-day, and 200-day moving averages. The share price of pharma heavyweight currently trades near its lowest level since November 2019. The stock has risen 8% in the last three years, while it has fallen 25% in the past one year. On the year-to-date (YTD) basis, it delivered a negative return of 26%, while it has tumbled 23% in the past six months.

On Wednesday, Biocon share price opened flat at ₹268.90 and declined as much as 2.4% to hit an intraday low of ₹262.40 on the BSE. The market capitalisation (m-cap) dipped to ₹32,110 crore with 1.48 lakh shares changing hands over the counter on the BSE by 1:00 PM. In contrast, the BSE Sensex was trading 340 points higher at 57,486 levels.

The stock was hammered after European Directorate for the Quality of Medicines & HealthCare (EDQM) on October 5 issued a list of deficiencies after conducting a good manufacturing practice (GMP) inspection of Biocon’s API manufacturing site in Bangalore from September 12-14.

“The European Directorate for the Quality of Medicines & HealthCare (EDQM) conducted a GMP inspection of an API manufacturing site of Biocon Limited in Bangalore from the 12th to 14th of September 2022 and issued a list of deficiencies on 5th October 2022. There were no critical deficiencies and one deficiency cited under the category ‘Major’,” Biocon says in an exchange filing on October 6.

The biopharmaceutical company said it remained committed to the quality, safety & efficacy of its products and will respond to the agency with appropriate corrective and preventive actions within the stipulated time.

Earlier in August, the U.S. health regulator, Food and Drug Administration (FDA), issued Form 483s with 11 observations each for Biocon’s sites in Bengaluru and six observations for a plant in Malaysia, following inspection of seven manufacturing facilities of its arm, Biocon Biologics. The Form 483 is issued to a company after at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The U.S. FDA observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerised tools to aid risk assessment & investigations and other procedural & facility upgrades. However, the company in a release said it did not expect the outcome of these inspections to impact the current supply of our products. 

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