Biocon plunges 4% as French regulator decides to re-inspect facility

NEW DELHI: Shares of drugmaker Biocon tumbled nearly 5 per cent on Monday after the company said that French drug regulator ANSM will re-inspect its facility even as it has received GMP approval for its biologics drug substance facilities.

While there were no critical observations mentioned in the final report, ANSM notified Biocon that the receipt of a GMP compliance certificate for the drug product facility will require a follow up inspection, Biocon said.

Following the announcement, the stock fell 9.51 per cent to hit a low of Rs 305 on BSE. It however recovered some losses and eventually ended the day 4.69 per cent down at Rs 321.25.

The re-inspection will be to verify implementation of the proposed corrective and preventive actions (CAPAs), the company said.

ANSM conducted pre-approval inspection audits of the Bangalore drug substance and drug product sites. The pre-approval inspection was conducted by ANSM pending the company's EMA marketing authorisation applications for trastuzumab and pegfilgrastim and related to insulin glargine (pen assembly only), Biocon said.