Aurobindo Pharma's Facility Receives OAI Classification From US FDA Following Inspection

US FDA classified Unit III of Aurobindo Pharma subsidiary Eugia Pharma as 'Official Action Indicated' (OAI) following an inspection. This news comes amid product recalls by Aurobindo Pharma due to manufacturing problems.

Aurobindo Pharma announced recently that an inspection is conducted by the USFDA at Unit III, a formulation manufacturing facility of Eugia Pharma Specialities, a wholly owned subsidiary. 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 classified the facility's inspection status as ‘Official Action Indicated’ (OAI). This classification implies that the regulatory body has identified significant issues that may require substantial corrective actions.

Aurobindo Pharma expressed its commitment to closely collaborating with the US FDA to enhance compliance continually. The company made this statement in a regulatory filing ahead of its March quarter earnings report, which is expected later in the day.

In related news, Aurobindo Pharma has been involved in product recalls in the US market due to manufacturing issues. According to a recent US FDA Enforcement Report, the company is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg) due to discoloration issues, specifically dotted and yellow spots on the tablets. This Class II recall was initiated on April 24, 2024.

Additionally, the US FDA has noted that FDC Ltd, another pharmaceutical firm, is recalling 382,104 units of Timolol Maleate Ophthalmic Solution, used to treat glaucoma, due to similar concerns. As per reports, a Class II recall is done when a violative product causes adverse health consequences either temporary or medically reversible, or when the probability of serious adverse health consequences is remote.

On May 24, shares of Aurobindo Pharma closed 0.3% higher at Rs 1,233.60 on the National Stock Exchange (NSE).