Biotechnology major Biocon today said that while it has received GMP approval for its biologics drug substance facilities from French Regulator ANSM, its drug product unit will need to be re-inspected.
The pre-approval inspection was conducted by ANSM pending the company's EMA marketing authorisation applications for trastuzumab and pegfilgrastim and related to insulin glargine (pen assembly only), Biocon said in a filing to BSE.
ANSM conducted pre-approval inspection audits of the Bangalore drug substance and drug product sites.
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, Biocon said.
The re-inspection will be to verify implementation of the proposed corrective and preventive actions (CAPAs).
Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) has reviewed the proposed CAPA plan and Biocon is progressing towards completion of the implementation of these CAPAs, it added.
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 authorisation applications with the goal of an early re- inspection, the company said.
"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," a company spokesperson said.
Biocon is committed to ensuring the highest level of quality in all of its products, the spokesperson added.
Disclaimer: No Business Standard Journalist was involved in creation of this content
