Biocon receives GMP compliance certificates for two facilities in Bangalore

From French Inspecting Authority (ANSM)

Biocon announced that the French inspecting authority (ANSM) conducted pre-approval inspection audits of its Bangalore drug substance and drug product sites related to pending EMA Marketing Authorisation Applications for Transtuzumab, Pegfilgrastim and related insulin glargine (pen aseemply only).

While there where 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.

ANSM has reviewed the proposed CAPA plan and Biocon is processing 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 follow up inspection of the drug product facility and the Marketing Authorisation Applications with the goal of an early re-inspection.

ANSM has issued GMP compliance certificates for the Company's two drug substance manufacturing facilities in Bangalore.

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