Aurobindo Pharma arm gets USFDA EIR for Telangana unit
Telangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for Unit-2, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Gaddapotharam Village IDA, Jinnaram Mandal, Sanga Reddy District, Telangana.
The inspection of the facility was conducted by the USFDA from September 23 to 27, 2024. Following the inspection, the unit initially received ten observations from the regulatory agency.
In a regulatory filing with the Bombay Stock Exchange (BSE), Aurobindo Pharma confirmed that the facility has now been classified under the Voluntary Action Indicated (VAI) category.
"The Unit has now received an Establishment Inspection Report (EIR) classifying the facility as Voluntary Action Indicated (VAI)," the company stated in a BSE filing.
Read also: Aurobindo Pharma arm Telangana facility gets 10 USFDA observations
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