Aurobindo Pharma’s Telangana API Facility Gets USFDA VAI Classification

28 Jan 2025 , 01:22 PM

Aurobindo Pharma has made an announcement on Tuesday, January 28, that the US Food and Drug Administration has issued an Establishment Inspection Report (EIR) related to its subsidiary’s API manufacturing facility in Telangana. It is situated in the Gaddapotharam village of the Sanga Reddy district and owned and operated by Apitoria Pharma Pvt Ltd. It has been categorized under Voluntary Action Indicated (VAI).

The USFDA inspected the Unit 2 API manufacturing facility of Apitoria Pharma during September 23 to September 27, 2024. Unit V of Apitoria Pharma received two procedural observations following a USFDA inspection carried out from December 9 to December 17, 2024. Aurobindo Pharma stated it will resolve the mentioned observations within the required timeline.

According to Investec, in a note, as one of the large and leading Indian pharmaceutical companies with a sizeable contribution to exports, Aurobindo Pharma stands the best position to benefit from the depreciating rupee.

VAI Classification: Reflecting on the manufacturing facilities of Aurobindo Pharma, classification under VAI has been marked for maintaining quality standards and staying in compliance.