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Aurobindo Pharma US arm gets USFDA EIR for Raleigh facility

Ruchika SharmaWritten by Ruchika Sharma Published On 23 Sept 2022 9:02 AM  |  Updated On 23 Sept 2022 9:02 AM
Aurobindo Pharma US arm gets USFDA EIR for Raleigh facility
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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.

Read also: Aurobindo Pharma subsidiary's plant gets one observation from USFDA

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.

Read also: Torrent Pharma to acquire skincare manufacturer Curatio Healthcare: Details


alembic pharmaalembic pharma newsRaleigh plantAurolife PharmaUSFDAUSFDA inspectionGMP inspection
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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