Biocon Biologics’ drug substance facilities in Bengaluru get EU GMP certification

PTI, May 12, 2020, 3:16 PM IST

Bengaluru: Biocon on Tuesday said its armBiocon Biologics has receivedEU Good Manufacturing Practice (GMP) certificationfor its biologics drug substance facilities in Bengaluru.

Biocon Biologics India has received the Certificate of GMP compliance fromEuropean Medicines Agency(EMA)represented by the competent authority of Germany for the facilities, the company said in a statement.

These facilities are used for the manufacture of drug substance of Pegfilgrastim and Recombinant human insulin and manufacturing related activities for insulin Glargine and insulin Aspart, it added.

The facilities were inspected by the regulatory agency between January 20-23, 2020, Biocon said.

“This certification will enable us to continue addressing the growing needs of patients in the EU markets and enhance access to our high quality biosimilars. We remain committed to global standards of quality and compliance,” a company spokesperson said.

Shares of Biocon Ltd were trading at Rs339.90 per scrip on the BSE, down 3.33 per cent from the previous close.