Biocon’s arm receives EIR from USFDA for Malaysia facility

01 Apr 2020 Evaluate

Biocon subsidiary -- Biocon Sdn Bhd has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) of its Insulins manufacturing facility in Malaysia, for Insulin Glargine. The inspection was conducted between February 10 and February 21, 2020.

The Inspection has been closed with a ‘VAI’ (Voluntary Action Indicated) classification in the EIR, for the three observations issued at the conclusion of the inspection in Feb 2020.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

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