Torrent Pharma's Indrad facility gets Form 483 with 5 observations from US FDA

Torrent Pharmaceuticals said that the company's Gujarat-based manufacturing facility received Form 483 with five observations from the United States Food and Drug Administration (US FDA).

In a regulatory filing made after market hours yesterday, the pharmaceutical company informed that the US FDA had conducted a pre-approval inspection (PAI) and a GMP inspection at the companys manufacturing facility situated in Indrad, Gujarat from 03 June 2024 to 12 June 2024.

At the end of the inspection, the company was issued a Form 483 with five observations. There was no observation related to data integrity reported.

We will respond to the USFDA within the prescribed time-frame and will work in close collaboration with the agency to address the observations at the earliest possible time, Torrent Pharma said in a statement.

Torrent Pharmaceuticals is the flagship company of the Torrent Group. It is ranked 6th in the Indian Pharmaceuticals Market and is amongst the top five in the therapeutics segments of cardiovascular (CV), gastro intestinal (GI), central nervous system (CNS), vitamins minerals nutritional (VMN) and cosmo-dermatology.

The companys consolidated net profit surged 56.45% to Rs 449 crore in Q4 FY24 as compared with Rs 287 crore recorded in Q4 FY23. Revenue from operations rose 10.2% year on year (YoY) to Rs 2,745 crore in the quarter ended 31 March 2024.

The scrip shed 0.14% to currently trade at Rs 2890.50 on the BSE.

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