Biocon Biologics Ltd has received the European Medicines Agency’s certification for good manufacturing practices for its biologics drug substance facility at Bengaluru, the company’s parent Biocon said in an exchange filing on Tuesday. The subsidiary of Biocon Ltd received the certification after the EMA’s representative conducted an inspection during 20-23 January, the company said.
“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,” a spokesperson for the company said.
The facility is used to manufacture the “drug substance of pegfilgrastim and recombinant human insulin and manufacturing related activities for insulin glargine and insulin as part,” Biocon said.