Torrent Pharma receives OAI from USFDA

Torrent Pharma has received a communication from the USFDA classifying the inspection conducted at its Indrad facility as official action initiated (OAI), on Monday.

The company in its exchange filing said that it has already submitted its initial response to USFDA, and commitments given in response to Form 483 observations have been fulfilled. The company is sending further updates post receiving of this OAI letter. The inspection was conducted in April 2019.

Further, the company clarifies that this classification will not disrupt supplies or the revenues from operations of this facility.

During first quarter of FY20, the company had filed 3 abbreviated new drug applications (ANDAs) and has around 11 tentative approvals and 34 ANDAs pending approvals from the FDA.

Torrent Pharmaceuticals is engaged in the research, development, manufacturing and marketing of generic pharmaceutical formulations in India, the US, Germany, Brazil and internationally. The company offers products in various therapeutic areas.

In response to this development, the stock of Torrent Pharma dipped nearly 5 per cent in early morning trade but later it recovered and at 15.11 hours, the stock was trading at Rs. 1,655 apiece, down by nearly 1.1 per cent.