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Torrent Pharma gets warning letter from US FDA for Gujarat facility

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The company is committed in maintaining the highest standards of compliances and quality manufacturing across all its facilities

Drug firm Torrent Pharmaceuticals 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 (US FDA) 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.

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

The company is also committed in 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.

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