Aurobindo Pharma turns volatile after US FDA issues 10 observations to Telangana-based unit

Aurobindo Pharma said that the US drug regulator has issued a 'Form 483' with 10 observations, post the inspection of the compay's Telangana-based unit.

The United States Food and Drug Administration (US FDA) inspected the company's unit - IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana, from 10 November to 18 November 2022.

The said Unit had been classified as 'official action indicated (OAI)' on 17 May 2019 and the company had responded to the agency and carried out the required corrective actions. Official Action Indicated (OAI) means regulatory and administrative actions will be recommended.

The US FDA Authorities have reinspected the facility as mentioned above. At the end of the inspection, the company has been issued a 'Form 483' with 10 observations.

"In our view, these observations are procedural in nature and not related to data integrity. The company will respond to the US FDA, within the stipulated timeline and shall work closely with the agency to address the observations at the earliest, Aurobindo Pharma said in a statement.

Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients.

The pharmaceutical company reported 41.3% fall in consolidated net profit to Rs 409.45 crore on a 3.7% decline in net sales to Rs 5,673.65 in Q2 FY23 over Q2 FY22.

After opening lower, the scrip managed to pare most losses as it attempted to move into the green. However, the selling pressure persisted, and the stock was currently down 0.32% to Rs 467.25 on the BSE.

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