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USFDA classifies insulins facilities of Biocon’s arm as voluntary action indicated

13 Jan 2025 Evaluate

The U.S. Food and Drug Administration (USFDA) has classified Biocon’s subsidiary -- Biocon Biologics’ Insulins facilities in Johor Bahru, Malaysia as Voluntary Action Indicated (VAI). This relates to the cGMP inspection conducted by the agency between September 15 - 27, 2024. The inspection scope had included several biologics manufacturing units comprising one Drug Substance and one Drug Product manufacturing units, one Medical Device Assembly unit, one Analytical Quality Control Laboratory, two Microbiological Control Laboratories and two Warehouses. 

Biocon Biologics remains committed to global standards of Quality and Compliance.

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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