Aurobindo Pharma gets USFDA OAI status for API facility in Hyderabad
Hyderabad: Drugmaker, Aurobindo Pharma, has recently announced that the company has received Official Action Indicated (OAI) status from United States Food and Drug Administration (USFDA) for the inspection conducted at its Unit I (API) manufacturing facility in Hyderabad, India.
The inspection was conducted between August 2 to August 12, 2021.
"The Company has received a communication from the USFDA classifying the inspection conducted at its Unit I (API) manufacturing facility in Hyderabad, India between August 2 to August 12, 2021 as Official Action Indicated (OAI), keeping the status unchanged," the company said in a BSE filing.
"The Company will be engaging with the regulator and is fully committed in resolving the status of this facility at the earliest," Aurobindo added.
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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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