Torrent Pharma Indrad facility gets USFDA warning letter

Published On 2019-10-10 06:14 GMT   |   Update On 2019-10-10 06:14 GMT

This action by the United States Food and Drug Administration (USFDA) follows earlier intimation received from the regulator in August 2019, wherein the agency had classified its inspection as "Official Action Indicated" (OAI), Torrent Pharma said in a regulatory filing.


New Delhi: Drug firm Torrent Pharmaceuticals recently said it has received a warning letter from the US health regulator for its Indrad facility in Gujarat.


This action by the United States Food and Drug Administration (USFDA) follows earlier intimation received from the regulator in August 2019, wherein the agency had classified its inspection as "Official Action Indicated" (OAI), Torrent Pharma said in a regulatory filing.


The company does not believe that the warning letter will have an impact of disruption of supplies or the existing revenues from operations of this facility, it added.


Read Also: Torrent Pharma Q1 net profit up 33 per cent to Rs 216 crore


"We will be engaging with the agency and are fully committed to resolving this issue at the earliest," Torrent Pharma said.




The company is also committed to maintaining the highest standards of compliances and quality manufacturing across all its facilities, it added.


The company, however, did not share any details about the concerns raised by the US regulator in its warning letter.


Read Also: Torrent Pharma expands recall of Losartan tablets in the US over carcinogen impurity

Article Source : PTI

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