Aurobindo Pharma Reports US FDA Inspection Status for North Carolina Facility as Voluntary Action Indicated
Aurobindo Pharma Limited has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) regarding its Raleigh Plant in North Carolina, USA. The facility, which is owned by Aurolife Pharma LLC, a wholly owned step down subsidiary of the company, has been classified as "Voluntary Action Indicated" (VAI).The inspection took place from March 24, 2025, to April 10, 2025. During the audit, Form 483 was issued, noting a total of 11 observations.
The USFDA has concluded that the inspection process is now closed following the issuance of the EIR and the classification of the plant as VAI.
The Raleigh Plant in North Carolina specializes in manufacturing Inhalers, Dermatology and Transdermal products. The successful completion and classification mean significant progress for the company's product pipeline.
As a result of the VAI status, pending applications for multiple inhalers and other dosage forms that originated from this facility can now advance through the USFDA’s review process.
AUROPHARMA Stock Price Movement
Aurobindo Pharma Limited shares tumbled on Friday, shedding 2.48% to settle at ₹1622.1 after trading in the stock market. The company closed down following a session high of ₹1670 and experienced a volume of 824,842 shares traded during the day.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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