These facilities were inspected by the regulatory agency between January 20 and 23, 2020
Biocon Biologics India, a subsidiary of Biocon 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 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,” informed a company release.
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