Biocon Biologics gets EU GMP Certification for Drug Substance Facilities, Bengaluru
Bengaluru: Biocon Biologics India Ltd., a subsidiary of Biocon Ltd. 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." Company Spokesperson
Biocon Limited is an innovation-led global biopharmaceuticals company committed to enhancing affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune.
It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as generic formulations in the US and Europe.