Torrent Pharma gains after receiving USFDA Establishment Inspection Report for its Dahej facility

Shares of Torrent Pharmaceuticals Limited gained 2 per cent in morning trade on Thursday after the company announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its manufacturing facility located in Dahej, Gujarat.

The EIR was received after the inspection was conducted by USFDA between May 17 and May 25, 2023, the pharma major said in a filing to the stock exchanges.

The EIR issuance marks the successful conclusion of the inspection process for the company’s Dahej facility. The facility was previously under the classification of "Official Action Indicated (OAI)" by the US drug regulator due to the inspection outcome in March 2019. The re-inspection was conducted in May 2023 and the Form 483 was issued with only two observations.

USFDA recommends VAI for Dahej facility

With the updated classification of the site as "Voluntary Action Indicated (VAI)" Torrent Pharmaceuticals is poised for the approval of filed Abbreviated New Drug Applications (ANDAs).At its Dahej facility Torrent Pharma manufactures Active Pharmaceutical Ingredients (APIs) and formulations for its international markets.

Torrent Pharma has recently joined the race to buy-out the Hamied family’s stake in rival pharmaceutical company Cipla, according to reports. However, the company will have to compete against the likes of Blackstone, one of the largest asset managers in the world, and Baring PE Asia-EQT.

Shares of Torrent Pharma gained 2 per cent to hit an intraday high of Rs 1,978.45 apiece on BSE in morning trade on Thursday. The stock was trading at Rs 1,962.10 per share, up 1.4 per cent, on BSE at 2:08PM.