The USFDA has issued Form 483 with five procedural observations for Torrent Pharma's oral-oncology facility in Gujarat, the latter said in a stock exchange filing on Tuesday.
The company added there was no observation related to data integrity reported.
The United States Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) at the company’s oral-oncology manufacturing facility located in Bileshwarpura, Gujarat from December 5 to December 11, the stock exchange filing stated.
"At the end of the inspection, the company was issued a Form 483 with 5 procedural observations, " Torrent Pharma said, adding that it would respond to the USFDA within the mentioned timeframe and will closely collaborate with it to resolve the observations.
In August, the USFDA closed the inspection of Torrent Pharma’s Dahej manufacturing facility in Gujarat, after inspecting it between May 17 and 25. The Dahej site was earlier placed under the 'Official Action Indicated (OAI)' classification based on a March 2019 inspection outcome.
The company reported a 23.7% year-on-year (YoY) surge in net profit at ₹386 crore for the second quarter that ended September 30, 2023. Its total revenue was at ₹2,660 crore, a jump of 16.1% against ₹2,291 crore in the corresponding period of the preceding fiscal.
Torrent Pharma's shares were trading 0.17% up at Rs 2,081.80 apiece at 11.30am.
(Edited by : Shloka Badkar)
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