USFDA issues warning letter to Torrent Pharma for Gujarat facility

It remains committed to being current good manufacturing practice (cGMP) compliant quality standards across all its facilities.

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USFDA
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Last Updated on January 26, 2023 by The Health Master

The drug company announced that it has received a communication from the US Food and Drugs Administration (USFDA) determining the inspection classification at the manufacturing facility at Indrad in Gujarat as official action indicated (OAI).

The company said that this inspection classification will not have impact on existing supplies or revenues from this facility.

Earlier on 28 September 2022, USFDA inspected company’s manufacturing facility at Indrad, Gujarat and issued Form 483 with 3 observations.

Torrent Pharmaceuticals said it continues to cooperate with the USFDA and will undertake all necessary remedial steps to resolve these issues to the satisfaction of the regulator.

It remains committed to being current good manufacturing practice (cGMP) compliant quality standards across all its facilities.

Torrent Pharmaceuticals is one of the leading Indian Pharmaceutical Company engaged in research, development, manufacturing and marketing of generic pharmaceutical formulations.

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