Aurobindo Pharma Ltd. on Monday said that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Andhra Pradesh unit with ‘Voluntary Action Indicated’ status.

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The US drug regulator inspected Aurobindo Pharma’s unit located in Anakapalli district of Andhra Pradesh, from May 15-19, 2023, the pharma company said in a filing to the stock exchanges on Monday.

Subsequently, the unit has obtained an Establishment Inspection Report classifying the facility as Voluntary Action Indicated (VAI).

As per the USFDA guidelines, the VAI inspection classification indicates that though investigators found and documented objectionable conditions during the inspection, no regulatory or enforcement action is recommended.

In November 2022, Aurobindo Pharma received an EIR from USFDA for its manufacturing facility at Pydibhimavaram in Andhra Pradesh. The company's facility was inspected by the US Food and drug regulator in February 2019 and issued a warning letter in June 2019.

Last week, the pharmaceuticals manufacturer announced that its wholly-owned subsidiary received approval from USFDA to manufacture and market Sevelamer Hydrochloride.

The new drug is used to control serum phosphorus in patients with chronic kidney disease on dialysis.

Aurobindo Pharma is the leading drug maker in India and it exports to over 155 countries across the globe with more than 90 percent of its revenues derived from international operations.

Shares of Aurobindo Pharma are trading 0.3 percent lower at Rs 737.