Biocon slips over 2% on 6 USFDA observations

NEW DELHI: Biocon shares slipped over 2 per cent on Thursday morning after the US health regulator issued six observations in Form 483 after pre-approval inspection of its insulin drug substance manufacturing facility in Bengaluru.

The scrip hovered at Rs 617, down 1.35 per cent at around 09:30 am while the benchmark BSE Sensex was up 0.17 per cent at 36,698.32.

"The USFDA concluded a pre-approval inspection of Biocon's insulin drug substance manufacturing facility triggered by a New Drug Application submitted by the company's insulin API customer," the company said.

"The inspection at the Bengaluru facility took place between February 25 and March 5, resulting in a Form 483 with six observations. Biocon is confident of addressing these expeditiously and remains committed to global standards of quality and compliance," it added.

Meanwhile, the shares of Biocon opened at Rs 609.80 on BSE against its previous closing of Rs 625.45.