Lupin receives Tentative Approval from U.S. FDA for Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablets

Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (FDA) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Emtricitabine and Tenofovir Alafenamide (DETAF) Tablets. This product would be manufactured at Lupin's Nagpur facility in India.

DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- & middle-income countries.

Commenting on the same, Mr. Naresh Gupta, President - API and Global Institution Business, Lupin said, "We are committed to providing affordable and quality treatment options to patients in low and middle-income countries. We are pleased that U.S. FDA has tentatively approved DETAF, which will significantly enhance our HIV portfolio."

Shares of Lupin Limited was last trading in BSE at Rs. 734.40 as compared to the previous close of Rs. 742.20. The total number of shares traded during the day was 24680 in over 1710 trades.

The stock hit an intraday high of Rs. 749.35 and intraday low of 730.20. The net turnover during the day was Rs. 18226380.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 TentativeApproval USFDA PEPFAR NDA DETAFTablets AIDSRelief