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

Biocon on Tuesday said its arm Biocon Biologics has received EU Good Manufacturing Practice (GMP) certification for its biologics drug substance facilities in Bengaluru.

May 12, 2020 / 02:17 PM IST

Biocon on Tuesday said its arm Biocon Biologics has received EU Good Manufacturing Practice (GMP) certification for its biologics drug substance facilities in Bengaluru.

Biocon Biologics India has received the Certificate of GMP compliance from European 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 Rs 339.90 per scrip on the BSE, down 3.33 per cent from the previous close.
first published: May 12, 2020 02:10 pm

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