Aurobindo Pharma’s Telangana unit gets 2 USFDA observations

18 Dec 2024 , 09:23 AM

Aurobindo Pharma Ltd announced that the United States Food and Drug Administration (FDA) concluded an examination of Unit-V, an active pharmaceutical ingredient (API) manufacturing facility of its wholly-owned subsidiary Apitoria Pharma Private Ltd.

The examination, which lasted from December 9 to 17, 2024, took place at the company’s factory in Telangana. The FDA concluded the inspection with two observations that were classified as procedural in nature. Aurobindo Pharma stated that the company will reply to these observations within the specified time limit.

The inspection concluded with 02 observations. The observations are procedural in nature and will be addressed within the allotted time. We will keep the stock exchanges updated if there is any additional information relevant to the foregoing in the future,” it stated. Aurobindo Pharma is committed to keeping the stock markets updated on any subsequent developments related to the examination.

The pharma player announced an 8.6% year-on-year (YoY) increase in net profit to ₹817 Crore in the second quarter ended September 2024, driven by strong sales in Europe and growing regions. The company made a net profit of ₹752 Crore in the same quarter the previous year. Quarter-on-quarter (QoQ), net profit fell 11%. Revenue from activities increased by 8% YoY to ₹7,796 Crore in Q2 FY25.

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