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Aurobindo Pharma informed that the United States Food and Drug Administration (US FDA) had inspected its Unit VI - B, a formulation manufacturing facility, situated at Chitkul village, Patancheru Mandal, Sangareddy district, Telangana, from 22 September 2023 to 29 September 2023. At the end of the inspection, a Form 483 was issued with 1 observation which is procedural in nature. An FDA Form 483 is a document issued by the US Food and Drug Administration (US FDA) to manufacturers of regulated products when it finds any conditions that may constitute violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or related laws and regulations. ?We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observation at the earliest,? the pharma company stated. Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients. The drug maker's consolidated net profit grew 9.7% to Rs 570.8 crore on 9.9% increase in total revenue from operations to Rs 6,850.5 crore in Q1 FY24 over Q1 FY23. Shares of Aurobindo Pharma rallied 4.60% to settle at Rs 914.20 on Friday, 29 September 2023. Powered by Capital Market - Live News
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