European Regulator Asks Biocon To Withdraw Two Drug Applications, Shares Fall
Shares of Biocon fell as much as 8.3 percent on Wednesday, the most in nearly two weeks
Shares of Biocon Ltd. fell as much as 8.3 percent on Wednesday, the most in nearly two weeks, after it said that European regulatory authorities wanted to reinspect the company’s facility that manufactures two drugs.
The European Medicines Agency (EMA) had asked it to withdraw applications for trastuzumab and pegfilgrastim until the Bengaluru-headquartered company fulfilled procedural requirement linked to re-inspection, Biocon said in an exchange filing.
The company said it is in the process of completing “corrective and preventive actions” by the end of the quarter ending September.
In another setback earlier this month, Biocon had said that the U.S. Food and Drug Administration had found 10 lapses in quality at its manufacturing facility in Bengaluru. The observations pointed at aseptic practices, it said in a statement.
Biocon shares have fallen 14.8 percent so far this month, compared to a 7 percent decline in the benchmark S&P BSE Healthcare Index.