Biocon falls 8% on heavy volumes

In past one month, the stock was down 21% against 2% decline in Sensex.

Biocon has dipped 8% to Rs 321 on BSE in intra-day trade on the back of heavy volumes on reports of withdrawal of Trastuzumab application.

On status of the European Medicines Agency (EMA) Dossiers, Biocon said that the European regulatory authorities had informed the company the need for a re-inspection of drug facility for Trastuzumab and Pegfilgrastim products.

The request for withdrawal of the dossiers and re-submission is part of the EMA procedural requirements linked to this re-inspection and will be considered by the EMA’s Committee of Medical Products for Human Use (CHMP), it added.

The company is on track to complete corrective and preventive actions (CAPAs) by the end of this quarter and it intend to seek re-inspection and re-submission thereafter.

On July 9, Biocon said, the French inspecting authority (ANSM) conducted pr-approval inspection audits of our Bangalore drug substance and drug product sites related to the pending EMA marketing authorization applications for Trastuzumab, Pegfilgrastim and related to Insulin Glargine (pen assembly only).

ANSM notified that the receipt of GMP compliance certificate for the drug product facility will require a follow up inspection from ANSM to verify implementation of the proposed corrective and preventive actions,” Biocon said in a regulatory filing.

At 12:00 pm; the stock was down 7% at Rs 324 on BSE, as compared to 0.23% rise in the S&P BSE Sensex. The trading volumes on the counter more than doubled with a combined 8.66 million shares representing 1.4% of total equity have changed hands on BSE and NSE so far.

In past one month, it underperformed the market, by falling 21% against 1.8% decline in the benchmark index.