Aurobindo Pharma arm Eugia's manufacturing unit is classified by the USFDA as official action suggested

The formulation manufacturing facility of Aurobindo Pharma arm Eugia in Pashamylaram, Telangana, has been designated as an official action indicated (OAI) by the US FDA.

Aurobindo Pharma said in a regulatory filing that it is "continually committed to working closely with the US FDA and to enhancing its compliance."

Unit III, a formulation production facility of Aurobindo Pharma's wholly owned subsidiary Eugia Pharma Specialities, was inspected by the US Food and Drug Administration (US FDA).

The plant located in Telangana's Sangareddy District was the subject of the inspection, which took place there between January 22 and February 2, 2024.

Consequently, this facility's inspection categorization status has been assessed by the US FDA to be "Official Action Indicated (OAI)".

Aurobindo Pharma said in a regulatory filing that it "remains committed to work closely with the US FDA as well as continues to enhance its compliance with regulations on an ongoing basis." Later in the day, the business is scheduled to release its profits for the March quarter.

Due to production problems, Aurobindo Pharma is recalling items in the US market, according to a USFDA Enforcement Report earlier this month.

13,605 bottles of 3.75 mg and 7.5 mg clorazepate dipotassium tablets—which are used to treat anxiety—are being recalled by the manufacturer from the American market. According to the USFDA, the company's US division is recalling the impacted lot because of "Discoloration: Dotted and yellow spots on tablets."

On April 24, the business started the Class II recall. The USFDA said that 3,82,104 units of Timolol Maleate Ophthalmic Solution, which is used as a treatment for glaucoma, are being recalled by another pharmaceutical company, FDC Ltd.

According to the USFDA, a Class II recall is started when there is little chance of major adverse health effects or when using or being exposed to a violative product may result in short-term or medically reversible adverse health effects.

Aurobindo Pharma's shares closed 0.3 percent higher on May 24 at Rs 1,233.60 over the National Stock Exchange (NSE). The stock has increased by around 104 percent over the last year, outpacing the 25 percent gain made by the Nifty 50.