The US Food and Drug Administration has classified Torrent Pharmaceuticals Ltd's facility in Indrad, Gujarat, as Official Action Indicated, the company said in an exchange filing today.
According to the corporate website, the facility, which has an annual capacity of 30 million vials, is where the company makes both formulations and Active Pharmaceutical Ingredients.
It also acts as a specialised facility for Novo Nordisk, a leading global maker of insulin.
According to the corporation, the US authority inspected the facility in September 2022 and issued Form 483 with three observations.
When an investigator discovers any food, medication, device, or cosmetic that is contaminated or likely to be adulterated and poses a health risk, a Form 483 is issued.
Any proposed regulatory or administrative action is indicated by the tag "Official Action Indicated." According to the corporation, the most recent development won't affect the Indrad facility's supply or earnings.
Shares of the business were down 0.4% at 1,591 rupees at 11:47 IST on NSE.
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