Torrent Pharma has received a communication from the US drug regulator 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 an impact on existing supplies or revenues from this facility.

Earlier on September 28, 2022, US FDA inspected the company's manufacturing facility at Indrad, Gujarat and issued Form 483 with 3 observations.

Torrent Pharma said it continues to cooperate with the US FDA 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.