US FDA classifies Aurobindo Pharma arm Eugia’s formulation manufacturing unit at Pashamylaram, Telangana as official action indicated (OAI)
MAY 25, 2024 / 12:21 PM IST
“The company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis,” Aurobindo Pharma said in a regulatory filing.
The United States Food and Drug Administration (US FDA) conducted an inspection at Unit III, a formulation manufacturing facility, of Aurobindo Pharma’s wholly owned subsidiary Eugia Pharma Specialities.
The inspection was conducted from January 22 to February 2, 2024, at the facility situated in Sangareddy District, Telangana.
Subsequently, the US FDA has determined the inspection classification status of this facility as ‘Official Action Indicated (OAI)’.
“The company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis,” Aurobindo Pharma said in a regulatory filing. The company is set to report its March quarter earnings later in the day.
Also Read | Neutral Aurobindo Pharma; target of Rs 1180: Motilal Oswal
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Earlier this month, USFDA in an Enforcement Report informed that Aurobindo Pharma is recalling products in the US market due to manufacturing issues.
The company is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg), used to treat anxiety, in the American market. The company’s US-based arm is recalling the affected lot due to “Discoloration: Dotted and yellow spots on tablets”, USFDA stated.
The company initiated the Class II recall on April 24. The USFDA stated that another drug firm FDC Ltd is recalling 3,82,104 units of Timolol Maleate Ophthalmic Solution, used to treat glaucoma, in the American market.
As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Also Read | Aurobindo Pharma falls after US FDA issues 3 observations on Andhra arm
On May 24, shares of Aurobindo Pharma ended 0.3 percent higher at Rs 1,233.60 on the National Stock Exchange (NSE). In the last one year, the stock has rallied nearly 104 percent, outperforming Nifty 50’s gain of 25 percent during this period.
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