Torrent Pharma: USFDA classifies Dahej facility as OAI

Torrent Pharma: USFDA classifies Dahej facility as OAI

Pratik Shastri
/ Categories: Trending, DSIJ News

Ahmedabad-based pharma major, Torrent Pharma informed in a press release that USFDA has classified its Dahej facility as Official Action Initiated (OAI). Reacting to this, the stock dipped more than 2.50 per cent in Thursday's trade.

The company has already submitted its initial response to USFDA and commitments given in response to the Form 483 observations have been fulfilled. The company is sending further updates over receiving the OAI letter. The company will be engaging with the regulator and is fully committed in resolving this issue at the earliest. The company does not believe that this inspection classification will have an impact on operations or revenues from this facility.

Recently, the company announced that it has entered a non-exclusive sub-licensing agreement to co-market sodium glucose co-transporter-2 (SGLT2) inhibitor, Remogliflozin Etabonate (Remogliflozin) in India with Glenmark Pharmaceutical. Under the terms of the agreement, Glenmark will receive license fees and royalties for the non-exclusive sub-license rights from Torrent. Glenmark will manufacture and supply Remogliflozin, while Torrent will market the drug under its own trademark Zucator, in India.

Reacting to the news, the stock touched an intraday low of Rs. 1,487.45 on Thursday. The stock closed at a loss of 2.50 per cent at Rs. 1,545.05 per share on BSE.

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