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Biocon Sdn Bhd, a subsidiary of Biocon Biologics, has been notified by the U.S. Food and Drug Administration (FDA) of an "OAI" (Official Action Indicated) classification for its insulins manufacturing facility in Johor, Malaysia. The classification could potentially result in delays or withholding of pending product approvals.
Biocon has submitted a comprehensive Corrective and Preventive Action (CAPA) plan in response to the FDA's observations from the inspection in July 2023. The company remains confident in completing all necessary actions as committed and will continue close engagement with the FDA. They anticipate minimal impact on the manufacturing and distribution of their commercial products for the U.S. market.
Biocon is an innovation led global biopharmaceuticals company, engaged in the production of therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.
The company reported 30% decline in consolidated net profit to Rs 101 crore in Q1 FY24 from Rs 144 crore in Q1 FY23. Consolidated revenues for Q1 FY24 grew 59% YoY to Rs 3,516 crore.
The scrip rose 0.08% to settle at Rs 254.35 on 17 October 2023.
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