Biocon: EU drug regulator approves Bengaluru facility

Leading biosimilars manufacturer Biocon Limited has received GMP compliance certificate from the European drug regulator for its Bengaluru facility located at Biocon Park.

The Biocon Park facility manufactures Biologics Drug Product (DP) and Drug Substance (DS) and engages in the production of the company's portfolio of biosimilars. The inspection was carried out by the European Medicines Agency (EMA) in March 2019. EMA conducts the scientific evaluation, supervision and safety monitoring of human and veterinary medicines for the European Union region (EU).

EMA has issued a Certificate of Good Manufacturing Practice (GMP) compliance following a surveillance inspection of Biocon's existing DP and OS facilities and a pre-approval inspection of the company's additional DP production line. This certification will provide further access to the EU markets and enhance the sales of Biocon's biosimilars in the region.

Also, Thursday, June 13, 2019 was the Record Date for eligible shareholders entitled to receive the bonus shares of the company.

Meanwhile, the stock of Biocon was quoting Rs. 250.20 per share, down by Rs. 6.20 or 2.42 per cent on Friday. The stock opened at Rs. 259.00, which is also its day's high on BSE.