Biocon has received the EU GMP certification, for its sterile drug product manufacturing facility.
The company stated, “We have received the European Union Good Manufacturing Practice (GMP) certification for the sterile drug product manufacturing facility in Bangalore.” This plant was inspected in the March 2018.
This facility is used for the manufacture of portfolio of biosimilars. Further, a company spokesperson stated, “The report lists six major observations with no observation classified as critical. We will submit a corrective and preventive action plan to the European inspection agency within the stipulated time period.”