Aurobindo Pharma Telangana facility gets USFDA EIR
Hyderabad: Aurobindo Pharma has announced that Unit VI-B, a Formulation manufacturing facility of the Company, situated at Chitkul Village, Patancheru Mandal, Sangareddy District, Telangana, has received Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) classifying the facility as "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 facility from September 22 to September 29, 2023 and issued one observation.
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 speciality 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, and Brazil ANVISA. The company’s product portfolio is spread over seven 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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