US FDA Designates Torrent Pharmaceutical’s Dahej Plant as VAI


The US Food and Drug Administration (FDA) has assigned a Voluntary Action Indicated (VAI) classification to Torrent Pharmaceutical’s manufacturing facility located in Dahej, Gujarat. This classification reflects that although some objectionable conditions or practices were identified during the inspection, the FDA is not inclined to take immediate administrative or regulatory action.

The Dahej site had previously received an ‘Official Action Indicated (OAI)’ classification in March 2019 following an inspection. The OAI classification indicates that the FDA found conditions warranting regulatory sanctions. However, the recent re-inspection conducted by the FDA between May 17 and May 25, 2023, resulted in the issuance of Form 483, listing two observations. Form 483 is a document given to a company’s management after an inspection, highlighting any observed conditions that could potentially violate relevant regulations.

The new VAI classification for the Dahej plant comes as a relief for Torrent Pharmaceuticals. The facility produces active pharmaceutical ingredients and formulations. With this classification, the company is expected to gain approval for its pending Abbreviated New Drug Applications (ANDAs) from this site. This development could have a positive impact on the company’s operations and its ability to distribute its pharmaceutical products in the US market.

Despite this news, the company’s shares experienced a decline of 2.13 percent on Wednesday, closing at Rs 1,935.05 per share on the Bombay Stock Exchange (BSE).

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