Aurobindo Pharma slides after Andhra unit gets Form 483 with 3 USFDA observations

Aurobindo Pharma fell 1.61% to Rs 565.60 after the company said that US drug regulator issued Form 483 with three observations after inspecting its manufacturing facility at Pydibhimavaram in Andhra Pradesh.

Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The Pydibhimavaram unit was classified as OAI (official action indicated) on 17 May 2019, and subsequently given a warning letter on 20 June 2019 by the United States Food and Drug Administration (USFDA), Aurobindo Pharma said in a regulatory filing on Tuesday, 2 August 2022.

The company responded to the warning letter and carried out the committed corrections. The USFDA authorities inspected the facility from 25 July to 2 August 2022.

"At the end of the inspection, we have been issued a Form 483 with three observations and none of these observations are related to data integrity," Aurobindo Pharma said.

The company will respond to the USFDA within the stipulated timeline and work closely with the regulator to address the observations at the earliest, it added.

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

The company's consolidated net profit declined 28.1% to Rs 576.46 crore on a 3.3% fall in net sales to Rs 5,795.34 crore in Q4 FY22 over Q4 FY21.

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