Biocon’s arm receives EU GMP Certification for Biologics Drug Substance facilities

12 May 2020 Evaluate

Biocon’s subsidiary---Biocon Biologics India has received the Certificate of GMP compliance from EMA represented by the competent authority of Germany for its Biologics Drug Substance (DS), facilities at 20th KM, Hosur Road, Bengaluru. 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 and were inspected by the regulatory agency between January 20 and 23, 2020.

This certification will enable company to continue addressing the growing needs of patients in the EU markets and enhance access to its high quality biosimilars. It remains committed to global standards of quality and compliance.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

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