Aurobindo Pharma US arm gets USFDA EIR for Raleigh facility

Hyderabad: Aurobindo Pharma has recently announced that Aurolife Pharma LLC, a wholly owned step-down subsidiary of the Company has received an establishment inspection report (EIR) mentioning the inspection as a voluntary action initiated (VAI) from the United States Food and Drug Administration (USFDA) after the USFDA pre-approval inspection and GMP inspection of plant situated at Raleigh, North Carolina, USA.

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.

Medical Dialogues team had earlier reported that the US health regulator had issued one observation after inspection of a plant owned by Aurobindo Pharma on Monday saidUS-based unit. 

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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 155 countries.

The company has 27 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.

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