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Biocon gets VAI classification from USFDA for Karnataka facility

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Last Updated : Dec 09 2024 | 11:04 AM IST

Biocon has announced that it has received the establishment inspection report (EIR) from the U.S. Food and Drug Administration (USFDA) for its active pharmaceutical ingredient (API) facility located at Jigani Link Road, Bengaluru, Karnataka.

The USFDA conducted an inspection of the facility from 23 September 2024 to 27 September 2024 and classified the inspection status as Voluntary Action Indicated (VAI).

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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First Published: Dec 09 2024 | 10:44 AM IST

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