AUROBINDO PHARMA LIMITED announced that its wholly owned step-down subsidiary, Aurolife Pharma LLC, received a ‘Voluntary Action Indicated’ (VAI) classification from the USFDA for its Raleigh Plant. This classification, following an inspection ending April 10, 2025, means pending applications for multiple inhalers and other dosage forms from this facility can now proceed through the USFDA’s review process.
AUROBINDO PHARMA Receives USFDA Classification for Raleigh Facility
AUROBINDO PHARMA LIMITED has been notified by the United States Food and Drug Administration (USFDA) regarding the classification of an inspection at its Raleigh Plant in North Carolina, USA. This facility is owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of AUROBINDO PHARMA. The plant is established for the manufacturing of Inhalers, Dermatology, and Transdermal products.
Inspection Details and Outcome
The USFDA conducted an inspection of the Raleigh Plant from March 24, 2025, to April 10, 2025. At the conclusion of the inspection, a Form 483 was issued with a total of 11 observations. Subsequently, the unit received its Establishment Inspection Report (EIR), which classifies the facility’s status as ‘Voluntary Action Indicated’ (VAI). The USFDA has confirmed that this inspection is now closed.
Implications for Product Approvals
The ‘VAI’ classification is a positive development for AUROBINDO PHARMA. It signifies that pending applications for multiple inhaler products and other dosage forms filed from this facility can now move forward and progress through the USFDA’s review process. This is expected to facilitate the advancement of new product approvals and subsequent market entry.
Source: BSE
