Aurobindo Pharma gets USFDA EIR for Telangana facility
Hyderabad: Aurobindo Pharma has announced that the company has received an Establishment Inspection Report (EIR) from United States Food and Drug Administration (USFDA) classifying the Company’s Unit III, a Formulation manufacturing facility situated at Bachupally Village, Medchal Malkajgiri District, Telangana 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.
USFDA had inspected the the said facility from July 14 to July 21, 2023 and issued Form 483 with 3 observations.
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 multiple 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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