Torrent Pharmaceutical gains on USFDA relief for Dahej plant

The FDA’s ‘voluntary action indicated classification’ means that Torrent Pharma will be now able to get approval for all pending Abbreviated New Drug Applications from the site

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Torrent Pharmaceuticals shares were trading higher on August 24, a day after the US Food and Drug Administration (USFDA) reclassified its Gujarat plant which will allow the company to get approval for pending drug applications.

The FDA granted “voluntary action indicated” classification to Torrent Pharma’s manufacturing site in Dahej, Gujarat.

The site was placed under “official action indicated” classification based on a March 2019 inspection outcome. The site was re-inspected by the USFDA between May 17 and May 25, 2023 and the officials had issued Form 483 with two observations.

Also read: USFDA grants VAI classification to Torrent’s Dahej facility

As per the USFDA, “Voluntary action indicated means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action”.

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The previous classification meant that “regulatory and/or administrative actions are recommended.”

According to a report, with the new classification the company will be now able to get approval for all pending ANDAs (Abbreviated New Drug Applications) from the site.

On August 23, a report indicated that the Ahmedabad-based pharmaceutical company was also entering the race to acquire Hamied family’s stake in pharmaceutical giant Cipla. Other names looking to buy the stake include Blackstone and Baring PE Asia-EQT.

Torrent Pharmaceuticals reported a healthy set of numbers for Q1FY24. It recorded a nearly 7 percent on-year rise in net profit for the quarter, while revenue grew 10.4 percent during the same period.

Brokerages foresee a strong growth outlook despite weak US business revenues.

Torrent Pharmaceuticals manufactures and distributes therapeutic drugs for the cardiovascular, central nervous system, gastro-intestinal and women health.

At 10.01 am, the stock was trading at Rs 1,950 on the National Stock Exchange,  up 0.59 percent from the previous close.

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