The drug manufacturing facility of Aurobindo Pharma’s subsidiary Eugia Pharma Specialties in Rajasthan has been topic to 9 surveillances by the US Meals and Drug Administration.
The US Meals and Drug Administration’s inspection of Unit II, a facility in Bhiwadi, Alwar, from November 3 to 14 concluded with 9 observations. These are procedural in nature and can be responded to inside a stipulated time. The event won’t influence the division’s present operations, the mum or dad firm stated in a submitting Friday.
Subject VAI to API unit
In a separate submitting, Aurobindo Pharma stated its subsidiary Apitria Pharma’s drug substance manufacturing facility (Unit I) in Sangareddy district of Telangana has acquired a facility inspection report from the US Meals and Drug Administration, classifying the ability as a Voluntary Motion Indication (VAI).
The corporate stated the U.S. Meals and Drug Administration issued a warning letter to the ability in January 2022 and subsequently performed an investigative inspection from Aug. 21 to 29, 2025, which the regulator concluded was closed. After finishing the inspection, Kind 483 was issued with 5 findings.
The US FDA subsequently accomplished an analysis of the corrective actions. Now we have decided that the problems described within the Warning Letter and Kind 483 have been adequately addressed. The unit has now acquired an EIR classifying the ability as a VAI.
Aurobindo Pharma shares closed 1.08% larger at ₹1,221.90 on the BSE on Friday.
VAI is one in every of three classifications issued by the US FDA to find out take a look at outcomes. A VAI implies that an unfavorable situation or follow has been found, however the regulator isn’t ready to take or suggest any administrative or regulatory motion. No Motion Indication (NAI) is one other classification that communicates that no objectionable situations or practices have been discovered through the inspection. The third classification class is OAI, which implies that official motion directed or regulatory and/or administrative motion is beneficial.
