Aurobindo Pharma gets USFDA EIR for Anakapalli facility

Published On 2023-07-17 05:59 GMT   |   Update On 2023-07-17 09:14 GMT

Hyderabad: Aurobindo Pharma has recently announced that the company has received Establishment Inspection Report from the U.S. Food and Drug Administration (USFDA) classifying the Anakapalli facility as "Voluntary action indicated" ("VAI").

Medical Dialogues team had earlier reported that the USFDA had conducted an inspection at Aurobindo Pharma Limited, Unit XIV, FEI 3014477031, located at Plot No 17, E-Bonangi Village, Jawaharlal Nehru Pharma City, Parawada Mandal, Anakapalli District, Andhra Pradesh, from 15th May to 19th May 2023 and issued
 four observations for the Company’s said facility.

Voluntary action indicated (VAI), means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. 

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.

Read also: Aurobindo Pharma arm CuraTeQ Biologics to commercialize proposed biosimilar to Stelara

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