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(15 Jun 2024, 16:32)

Biocon’s Andhra Pradesh facility gets 3 USFDA observations

Biocon said that US Food and Drug Administration (USFDA) issued three observations after the good manufacturing practices (GMP) inspection conducted at its API manufacturing facility situated at Visakhapatnam, Andhra Pradesh.


The good manufacturing practices was conducted on 14 June 2024 and closed the inspection with three observations. The company said that it will respond to the USFDA within the stipulated timeframe.

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 had reported 56.74% decline in consolidated net profit to Rs 135.5 crore despite of 3.79% rise in revenue from operations to Rs 3,917.1 crore in Q4 FY24 over Q4 FY23.

The scrip fell 1.06% to end at Rs 334.65 on Friday, 15 June 2024.

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