Category: Approval/Launch Region: Asia · India Company: Aurobindo Pharma Ltd

Aurobindo Pharma's unit VII facility gets OAI from US FDA

Aurobindo Pharma's unit VII facility gets OAI from US FDA
Aurobindo Pharma announced that the US Food and Drug Administration (FDA) classified the inspection of the company's oral solids formulation manufacturing facility of Unit VII as official action indicated (OAI). "The company believes that this OAI classification will not have any material impact on the existing revenues or the supplies to our US business at this juncture," Aurobindo Pharma said in a BSE filing. The company will work closely with the regulator to comprehensively address the issues

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