The biotechnology major said the US health regulator has issued three observations after inspecting its Telangana-based manufacturing plant.
The US Food and Drug Administration (USFDA) concluded a pre-approval inspection for Site 3 located at Hyderabad on 20 July 2022."US FDA concluded a pre-approval inspection for Site 3, Biocon Limited, located at Hyderabad, Telangana on 20 July 2022. Three observations were cited at the end of the Inspection, which we will be addressing within the stipulated time. Biocon stands committed to the Quality, Safety & Efficacy of its products," Biocon said in a statement on Thursday, 21 July 2022.
Biocon is a global biopharmaceutical company committed to enhancing affordable access to complex therapies for chronic conditions like diabetes, cancer, and autoimmune.
The company reported 6% fall in consolidated net profit to Rs 239 crore on a 31% rise in revenue from operations to Rs 2,409 crore in Q4 FY22 over Q4 FY21.
Shares of Biocon rose 1.63% to Rs 331.35 on Thursday, 21 July 2022.
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