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healthcare | IST

Aurobindo Pharma unit gets warning letter from USFDA

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Aurobindo Pharma shares fell about 3 percent on Wednesday after it's unit XI facility received a warning letter from the USFDA.

Aurobindo Pharma shares fell about 3 percent on Wednesday after it's unit XI facility received a warning letter from the USFDA.
Three of Aurobindo's units, that is Unit I, Unit IX as well as Unit XI, had received an official action indicated status from the USFDA in May but now, Unit XI has been downgraded with a warning letter.
The warning letter is centered on the issue of the manufacture of Valsartan API. The management has been communicating to investors with regards to all the issues associated with these three plants.
As per the warning letter, the company has to review all the API batches and provide a retrospective review of all distributed batches within expiry.
The regulator also pointed out repeat observations at multiple sites and cited similar CGMP observations at other facilities.