Torrent Pharmaceuticals Limited has received a US Food and Drug Administration (USFDA) inspection classification ‘Official Action Indicated’ (OAI) for the company’s Indrad facility in Gujarat.
In a regulatory filing on Tuesday, the company said that after the USFDA inspection at the company’s manufacturing facility in Indrad, Gujarat, and issuance of Form 483 with three observations, the company received a communication from the US drug regulator with the OAI inspection classification.
“This inspection classification will not have impact on existing supplies or revenues from this facility,” the company said.
Torrent makes formulations and active pharmaceutical ingredients (API) at the facility, which has an annual capacity of 30 million vials, the company’s website stated.
The OAI suggests that a regulatory or administrative action could be recommended.
Torrent Pharmaceuticals shares traded at ₹1,589.90, down by 0.5 per cent from the previous close on NSE.