Aurobindo Pharma Limited shares closed in the red on Friday ending three-day gaining streak after the company announced receiving a warning letter from the United States Food and Drug Administration (USFDA) for one of the manufacturing units of its subsidiary.
In a filing to the stock exchanges, Aurobindo Pharma said that the US drug regulator has issued a warning letter to the unit-III of the formulation manufacturing facility of Eugia Pharma Specialties Limited.
Eugia Pharma is a wholly-owned subsidiary of Aurobindo Pharma.
Earlier in May, the company had informed that Eugia Pharma’s unit-III of the formulations manufacturing facility received a Official Action Indicated (OAI) recommendation in the inspection closure report by the USFDA.
Shares of Aurobindo Pharma opened marginally higher at Rs 1525 per piece on the NSE on Friday. However, the stock dropped more than 6% to an intraday low of Rs 1,421.45 per share. However, the stock recovered some of the losses to close at Rs 1,496.7 apiece, down 1.51%.
Aurobindo Pharma said that it is committed to working closely with the USFDA to enhance its compliance continuously. It is worth noting that USFDA officials inspected Unit-III, the manufacturing facility of Eugia Pharma Specialties Limited in Telangana from January 22 to February 2.
In an interaction with CNBC-TV18, the drugmaker’s management remained confident of the company’s arm Eugia clocking in sales of $600 million (approx Rs 497 crore) in FY25. The US market makes up 47 per cent of Aurobindo Pharma’s total sales. For the June quarter, US sales reached $426 million (Rs 3,500 crore), slightly lower than the $432 million (Rs 3,626 crore) reported in the March quarter.
According to the USFDA rules, OAI implies that the regulator may withhold approval of any pending product application or supplement of such plant until pending action related to non-compliance with manufacturing norms prescribed by it is completed.
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