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The EIR is based on a surveillance inspection conducted by the United States Food and Drug Administration (USFDA) from the 16th to 20th of September 2024.
Meanwhile, the pharma company and Zentiva, its European partner, received a de-centralized procedure (DCP) approval for its complex formulation, Liraglutide, in the European Union (EU).
The approval is for the generic versions of Victoza to treat type-2 diabetes and Saxenda used in the treatment of weight management.
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 a consolidated net loss of Rs 16 crore in Q2 FY25 as against a net profit of Rs 126 crore in Q2 FY24. Revenue from operations rose by 4% YoY to Rs 3,590 crore during the quarter.
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