Tough times again for Aurobindo Pharma as USFDA reverses stance
Live MintMumbai: The US Food and Drug Administration has done the unusual. Three days after issuing a voluntary-action-indicated status for Aurobindo Pharma's Unit IV, the regulator on Friday told the company that the inspection of the unit remains open and is being reviewed. This unit also has the largest number of new drug applications pending approval at about 47 compared with the company's total pending applications at about 150. Graphic by Santosh Kumar Sharma/Mint “The rescinding of the VAI status for Unit-IV now places our US$280 mn and US$343 mn revenue forecasts for the sterile business in FY2021/22 at risk, with potential for a 20% haircut on injectable revenues in FY2021/22 should the issue escalate to an Official Action Indicated or Warning Letter,” said analysts at Kotak Institutional Equities in a note to clients. With the attendant scrutiny and increasing pressure, Aurobindo Pharma may also incur higher costs to comply with US FDA regulations.
History of this topic
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