New Delhi: Biotechnology major Biocon said it has received EU GMP certification for its sterile drug product manufacturing facility in Bengaluru.
The facility was inspected by the European agencies in March 2018, Biocon said in a filing to BSE.
“This facility is used for the manufacture of Biocon’s portfolio of biosimilars,” a company spokesperson said.
Earlier in May, in a regulatory filing, Biocon had said it had received a preliminary report from the European Regulator post inspection of its sterile drug product facility in Bengaluru in March 2018.
“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,” a company spokesperson had said.