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USFDA issues 14 observations to Aurobindo Pharma's Pashamylaram facility; shares slump 9%

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Aurobindo Pharma has received some observations from the US Food and Drug Administration (USFDA) for its unit 4. Find out what are these observations.

Drug major Aurobindo Pharma has informed that the United States Food and Drug Administration (US FDA) has issued a 'Form 483' with 14 observations to its general injectable formulation manufacturing facility located at Pashamylaram, Hyderabad.
Aurobindo Pharma shares slumped as much as 9.4 percent intraday to its 52-week low of Rs 392.60 per share on the BSE.
The inspection was carried between November 4 to 13 and while the details of the observations are not released.
"We believe that none of these observations is related to data integrity issues. The Company will respond to the US FDA within the stipulated timeline," Aurobindo Pharma said in a regulatory filing.
The unit has 47 new drugs, representing 30 percent of their overall filings and 50-60 percent of their total injectable sales, which is basically one of their key growth drivers from this particular plant.
The company already have pending issues in Unit-1, now Unit-4, Unit-9 and Unit-11 and Unit-7 has also received seven observations.
This makes around 50 percent of the company's total new filings from all these facilities which are impacted by some other regulatory issues.

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