Torrent Pharmaceuticals said that the US FDA issued Form 483 to the company with 3 observations post the inspection of the drug maker's Indrad-based manufacturing facility.
In an exchange filing made after market hours yesterday, the company said that the United States Food and Drug Administration (US FDA) had inspected its manufacturing facility at Indrad, Gujarat from 19 September 2022 to 28 September 2022.
At the end of the inspection, the company was issued a Form 483 with 3 observations.
"None of these observations were related to data integrity. We will respond to the USFDA within stipulated timeline and work closely with USFDA to address the observations at the earliest, the company said in a statement.
Torrent Pharmaceuticals is the flagship company of the Torrent Group. It is ranked 8th in the Indian pharmaceuticals market and is amongst the top 5 in the therapeutics segments of cardiovascular (CV), gastrointestinal (GI), central nervous system (CNS), and vitamins minerals nutritionals (VMN).
The pharma giant's consolidated net profit rose 7% to Rs 354 crore on 10% increase in net revenue from operations to Rs 2,347 crore in Q1 FY23 over Q1 FY22.
Shares of Torrent Pharma rose 0.54% to currently trade at Rs 1502.90.
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