Aurobindo Pharma gets Form 483 with 10 observations from USFDA

Aurobindo Pharma announced that the United States Food and Drug Administration (USFDA) has issued Form 483 with 10 observations after the inspection of its unit IX, Gundlamachnoor facility.

The drug maker said that the unit - IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana had been classified as OAI (official action indicated) on 17 May 2019 and the company had responded to the agency and carried out the required corrective actions.

The US drug regulator reinspected the facility from 10 November 2022 to 18 November 2022.

At the end of the inspection, the pharmaceutical company was issued a Form 483 with 10 observations. The observation is procedural in nature and not related to data integrity, the pharma company stated.

The pharma major added that it 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 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.

Shares of Aurobindo Pharma were down 1.13% to Rs 468.75 on Friday, 18 November 2022.

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