Biocon's subsidiary receives six observations from USFDA

Biocon on Saturday announced that the USFDA has issued six observations after the inspection of the manufacturing facility of its Malaysian subsidiary Biocon Sdn Bhd.

The US Food and Drug Administration (USFDA) conducted an on-site pre-approval inspection of the company's Malaysian subsidiary Biocon Sdn Bhd's manufacturing facility for Insulin Aspart between 13 September and 24 September, Biocon said in a statement.

A Biocon spokesperson said the company is confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan (CAPA), which will be submitted to the USFDA in the stipulated time. He further added that the company does not expect the outcome of the inspection to impact commercialization plans for insulin Aspart in the US. Biocon Biologics remains committed to global standards of Quality and Compliance.

Biocon is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune.

The company's consolidated net profit declined 43.5% to Rs 84.4 crore in Q1 FY22 from Rs 149 crore in Q1 FY21. Revenue from operations increased by 4% YoY to Rs 1,761 crore in Q1 FY22 from Rs 1693.8 crore in Q1 FY21

Shares of Biocon ended 2.07% lower at Rs 360.20 on Friday.

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