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Hot Pursuit News

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(13 Jun 2024, 09:20)

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 company’s 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 ...

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