USFDA issues warning letter to AuroLife Pharma New Jersey unit
"The company will be engaging with the regulator and is fully committed in resolving this issue at the earliest," it added.
New Delhi: Drug firm Aurobindo Pharma Thursday said its step-down subsidiary has received a warning letter from the US health regulator for its unit in New Jersey, US.AuroLife Pharma, a wholly-owned step-down subsidiary of the company, has received a warning letter from the United States Food and Drug Administration (USFDA) for its oral solid manufacturing facility situated at Dayton, New...
New Delhi: Drug firm Aurobindo Pharma Thursday said its step-down subsidiary has received a warning letter from the US health regulator for its unit in New Jersey, US.
AuroLife Pharma, a wholly-owned step-down subsidiary of the company, has received a warning letter from the United States Food and Drug Administration (USFDA) for its oral solid manufacturing facility situated at Dayton, New Jersey, Aurobindo Pharma said in BSE filing.
This follows the earlier letter dated June 4, 2020, issuing an OAI (Official Action Indicated) status for this facility.
Aurobindo Pharma said it believes the existing business from this facility will not be impacted.
Read also: Aurobindo Pharma, CSIR join hands to develop COVID-19 vaccine
"The company will be engaging with the regulator and is fully committed in resolving this issue at the earliest," it added.
The drug firm, however, did not provide any details of the contents of the warning letter.
Read also: Aurobindo Pharma, BIRAC join hands for COVID vaccine development
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