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USFDA completes inspection at Biocon’s Insulins facilities in Malaysia

08 Jul 2019 Evaluate

US Food and Drug Administration (USFDA) has completed inspection at Biocon’s Insulin Glargine Drug Substance, Drug Product and Device assembly facilities in Malaysia. A per-approval inspection by USFDA was carried out from June 24 and July 5, 2019. The inspection across these 3 units concluded with 12 observations issued on the Form 483.

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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363.50 5.00 (1.39%)
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