Aurobindo's Unit I gets warning letter from US FDA; shares drop 4.5%
Aurobindo Pharma share price: Shares of Aurobindo Pharma fell as much as 4.5 percent on Friday as the company's Unit I in Hyderabad has received a warning letter from the US Food Drug and Administration (US FDA). In November, Aurobindo Pharma had said that the US drug regulator had classified the inspection conducted at its Unit I in Hyderabad between August 2-12, 2021 as Official Action Indicated (OAI). The company’s Unit-1 makes active pharmaceutical ingredients and the US drug regulator, in November, had issued Form 483 with seven observations to Unit I.
Shares of Aurobindo Pharma fell as much as 4.5 percent on Friday after the company's Unit I in Hyderabad received a warning letter from the US Food Drug and Administration (US FDA).
At 11:29 am, shares of the company were down 3.9 percent at Rs 689.95 on BSE. It was the second-biggest loser on Nifty500.
“…with regard to the OAI classification of our Unit I, an API manufacturing facility of the Company in Hyderabad, we inform that the Company has received a warning letter from the USFDA for the said Unit,” Aurobindo Pharma said in an exchange filing.
“The Company believes that this will not impact the existing business from this facility,” the company said.
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Aurobindo Pharma also said that it will be engaging with the regulator and is fully committed to resolve this issue at the earliest. The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, it added.
This warning letter follows the recent inspection of the Unit by the US FDA in August.
In November, Aurobindo Pharma had said that the US drug regulator had classified the inspection conducted at its Unit I in Hyderabad between August 2-12, 2021 as Official Action Indicated (OAI).
The company’s Unit-1 makes active pharmaceutical ingredients and the US drug regulator, in November, had issued Form 483 with seven observations to Unit I.
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