Aurolife Pharma LLC receives 11 observations from USFDA for Raleigh Plant

The United States Food and Drug Administration (USFDA) inspected Raleigh Plant, North Carolina, USA, owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of Aurobindo Pharma Ltd, established for manufacturing Inhalers, Dermatology and Transdermal products, from March 24, 2025, to April 10, 2025. At the end of inspection, form 483 was issued with a total of 11 observations.

The Unit has now received Establishment Inspection Report (EIR), classifying the facility as "Voluntary Action Indicated" ("VAI"). The USFDA has concluded that this inspection is now closed.

As this unit is classified as VAI, pending applications for multiple inhalers and other dosage forms filed from this facility can now progress through the USFDA's review process.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1625.00 as compared to the previous close of Rs. 1658.00. The total number of shares traded during the day was 22762 in over 2334 trades.

The stock hit an intraday high of Rs. 1651.10 and intraday low of 1618.80. The net turnover during the day was Rs. 37222123.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 Pharmaceuticals AurolifePharmaLLC USFDA VAI RaleighPlant