ICICI Securities Limited
In a recent update, Aurobindo Pharma's Unit-7 has received Form 483 from USFDA with seven observations. The USFDA conducted cGMP related inspection at this unit from September 19-27, 2019. As per media reports, this plant is contributing 25-30% to US revenues. The company has ~33 pending USFDA approvals as of Q1FY20 from Unit VII. We believe the observations are critical and the company is likely to face further remedial action from the USFDA like warning letter or in worst case scenario an import alert. We await further action from the USFDA. Although the...
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