Aurobindo Pharma arm Telangana injectable unit gets USFDA VAI classification

Telangana: Aurobindo Pharma has informed in a BSE filing that the injectable facility of Eugia SEZ Pvt. Ltd., a 100 per cent step-down subsidiary of Aurobindo Pharma Ltd., situated at Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Telangana has received Establishment Inspection Report from the U.S. Food and Drug Administration (US FDA).

The US FDA has categorized the facility under "Voluntary Action Indicated" (VAI). VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

The USFDA had inspected the said facility from February 19 to February 29, 2024 and concluded an inspection with 7 observations.

Read also: USFDA issues 7 observations for Aurobindo Pharma arm Telangana injectable facility

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The Company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

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