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Torrent Pharma Shares Fall as USFDA Concludes Inspections

A pre-approval inspection was conducted by the USFDA at the company’s Oral-oncology manufacturing facility.

Shares of Torrent Pharma were trading in the red and 2% lower on 12 December after the USFDA (US Food and Drug Administration) completed the inspection of the company’s oral-oncology manufacturing facility in Bileshwarpura, Gujarat.

In its regulatory filing, the company said that the USFDA conducted a pre-approval inspection at the company’s oral-oncology manufacturing facility in Bileshwarpura, Gujarat, between 5 and 11 December.

The US regulatory completed the inspection and issued a Form 483 with 5 procedural observations. However, the regulator reported no observations related to data integrity.

The company said, “We will respond to the US FDA within the prescribed time-frame and will work in close collaboration with the agency to address the observations at the earliest possible time.”

Earlier in December, it was announced that the USFDA is conducting inspections of facilities belonging to companies, including Torrent Pharma, Laurus Labs, Dr Reddy’s, and Sun Pharma.

In its quarterly report for July-September, the company reported a 24% year-on-year (YoY) increase in its net profit to Rs 386 crore for the quarter on the back of strong revenue from Brazil, India, German operations despite the decline in the US segment.

At 3:30 pm, the shares of Torrent Pharma closed 2.03% lower at Rs 2,036.25 on NSE.

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