Aurobindo Pharma Ltd on Tuesday informed the stock exchanges that the United States Food and Drug Administration (USFDA) has concluded the inspection of one of its manufacturing facilities with voluntary action indicated (VAI) in its Establishment Inspection Report (EIR).

The unit under discussion is an active pharmaceutical ingredients (API) and intermediates facility located in Telangana that was inspected by the US drug regulator from November 10 to November 18, 2022.

VAI is the second-best classification that a plant can get from the USFDA after ‘No Action Indicated’. According to the guidelines, the VAI classification is issued when ‘objectionable conditions or practices are found during the inspection but the agency is not prepared to take or recommend any administrative or regulatory action’.

In a stock exchange notification on Tuesday, Aurobindo Pharma said, “As per the information available on the FDA website, the company’s Unit-IX, an API intermediate facility situated at Gundlamachnoor Village, Sangareddy District, in Telangana, has now been classified as Voluntary Action Indicated (VAI).”

In November 2022, USFDA had issued 10 observations after the inspection of the pharma company’s Unit-IX. The unit was classified as Official Action Indicated (OAI) on May 17, 2019, and the company had carried out the required corrective actions.

Reacting to the development, shares of Aurobindo Pharma were trading flat on Tuesday on BSE around noon after falling as much as 1.7 percent earlier in the session.

Last week, the pharma company announced that its net profit dropped 19 percent year-on-year to Rs 491 crore in the December quarter from Rs 604 crore in the corresponding period a year ago. It missed the CNBC-TV18 poll estimates of Rs 532.9 crore of profit for Q3 FY23.

However, its consolidated revenue from operations during the quarter grew 6 percent to Rs 6,407 crore from Rs 6,002 crore in the year-ago quarter. On the revenue front, Aurobindo Pharma beat the Street estimates of Rs 5,944 crore.

The board of directors of the company has approved an interim dividend of Rs 3 per equity share of Re 1 each. The interim dividend will be paid on or before March 3, 2023, with the record date being February 17.

https://www.cnbctv18.com/market/aurobindo-pharma-shares-gains-even-as-third-quarter-profit-sinks-board-declares-dividend-15906571.htm

https://www.cnbctv18.com/market/stocks/aurobindo-pharma-unit-ix-telangana-usfda-10-observations-15217681.htm

(Edited by : C H Unnikrishnan)

First Published:Feb 14, 2023 1:12 PM IST