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The US Food and Drug Administration (USFDA) conducted an on-site pre-approval inspection (PAI) of Biocon's Malaysian subsidiary Biocon Sdn. Bhd's manufacturing facility for insulin aspart between 13 and 24 September 2021.
At the conclusion of the inspection, the agency has issued a Form 483 with a total of 6 observations across drug substance, drug product and devices facilities.
"We are confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan (CAPA), which will be submitted to the US FDA in the stipulated time. We do not expect the outcome of this inspection to impact our commercialization plans for insulin Aspart in the US. Biocon Biologics remains committed to global standards of Quality and Compliance," a company spokesperson said.
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.
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