“The French inspecting authority (ANSM) conducted pre-approval inspection audits of our Bangalore drug substance and drug product sites related to the pending EMA Marketing Authorization Applications for Trastuzumab, Pegfilgrastim, and related to Insulin Glargine.
While there were no critical observations mentioned in the final report, ANSM notified Biocon that the receipt of a GMP compliance certificate for the drug product facility will require a follow up inspection from ANSM to verify implementation of the proposed corrective and preventive actions (CAPAs). ANSM has reviewed the proposed CAPA plan and Biocon is progressing towards completion of the implementation of these CAPAs. Biocon, with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow-up inspection of the drug product facility and the Marketing Authorization Applications with the goal of an early re-inspection.
We are pleased however that ANSM has issued GMP compliance certificates for our two drug substance manufacturing facilities in Bangalore. This is important as the drug substance manufacture is core to the production of the actual biologic product in GMP compliance. Biocon is committed to ensuring the highest level of quality in all of its products.” - Company Spokesperson
