Aurobindo Pharma: The United States Food and Drug Administration (US FDA) recently inspected Unit III, A formula production facility of Aurobindo Pharma’s entirely owned subsidiary, Eugia Pharma Specialities. The inspection took place from January 22 to February 2, 2024, at the facility located in Sangareddy District, Telangana.
Following the inspection, the US FDA has classified the facility’s status as ‘Official Action Indicated (OAI)’. In a regulatory filing, Aurobindo Pharma stated that the company remains committed to working closely With the United States FDA and maintains to beautify its compliance on an ongoing basis. The company is also scheduled to report its March quarter earnings later today.
Earlier this month, the US FDA announced in an Enforcement Report that Aurobindo Pharma is recalling products in the US market due to manufacturing issues. The organization is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75mg and 7.5 mg), used to deal with anxiety, from the United States market. According to the US FDA, the company’s US-based arm is recalling the affected lot due to “discoloration: dotted and yellow spots on tablets.
The business enterprise initiated the Class II don’t forget on April 24. The US FDA also reported that another pharmaceutical company, FDC Ltd, is recalling 382,104 devices of Timolol Maleate Ophthalmic Solution, used to deal with glaucoma, from the United States market. According to the United States FDA, a Class II remember is initiated whilst the usage of or publicity of a violative product may cause temporary or medically reversible adverse health consequences, or when the likelihood of serious adverse health consequences is remote.
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On May 24, shares of Aurobindo Pharma closed 0.3 percent higher at Rs 1,233.60 at the National Stock Exchange (NSE). Over the past year, the stock has surged nearly 104 percent, significantly outperforming the Nifty 50’s 25 percent gain during the same period.
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