Shares of Torrent Pharmaceuticals Ltd gained as much as 1.7 percent in the morning trade on Thursday after the company informed that United States Food and Drug Administration (USFDA) has now formally closed the inspection of its Dahej manufacturing facility in Gujarat.
The stock hit an intra-day high of Rs 1,967.90 per share on BSE on Thursday. By 10:36 AM, the shares pared some of its gains to trade at Rs 1,957 apiece, up 1.1 percent.
To recall, the US drug regulator had conducted an inspection at the Dahej facility from May 17, 2023 to May 25, 2023. Torrent Pharma in a statement to exchanges said, “The USFDA has issued an Establishment Inspection Report (EIR) for the said manufacturing facility and the inspection has now been successfully closed.”
The EIR is the final inspection report of a USFDA inspection. It contains important information on how the FDA approached their inspections at a manufacturing facility and how it viewed compliance in light of the ongoing regulations in place.
As per the information available on its website, the US health regulator has granted ‘Voluntary Action Indicated (VAI)’ classification to Torrent Pharma’s Dahej manufacturing site.
A VAI classification means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
The VAI classification for the Dahej plant would be a great relief for Torrent Pharma, which produces active pharmaceutical ingredients (APIs) and formulations at the site. The classification indicates that the company will be now able to get approval for all pending ANDAs (Abbreviated New Drug Applications) from the site.
The Dahej site was earlier placed under the 'Official Action Indicated (OAI)' classification based on a March 2019 inspection outcome. OAI means "objectionable conditions were found and regulatory administrative sanctions by USFDA are indicated”.
The Dahej site was later re-inspected by the USFDA and the officials, subsequently, issued Form 483 with two observations.
