US FDA classifies inspection at Torrents Dahej unit as OAI
Torrent Pharmaceuticals announced that it has received a communication from the United States Food and Drug Administration (FDA) classifying the inspection conducted at its Dahej facility in March, 2019 as Official Action Initiated (OAI).
The company had submitted its initial response to USFDA and commitments given in response to Form 483 observations have been fulfilled.
The company is sending further updates over receiving of this OAI letter. The company will be engaging with the regulator and is fully committed in resolving this issue at the earliest.
The company does not believe that this inspection classification will have an impact of disruption of supplies or the revenues from operations of this facility.
Torrent Pharma, the flagship company of Torrent Group is one of the leading pharma companies. The company has significant presence in diabetology, pain management, gynaecology, oncology and anti-infective segments.