Lupin receives tentative U.S. FDA approval for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) Tablets under PEPFAR

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, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) Tablets, 50 mg/300 mg/300 mg, and antiretroviral Fixed Dose Combination (FDC). This product would be manufactured at Lupin's Nagpur facility in India.

TLD is recommended by World Health Organisation (WHO), the U.S. Agency for International Development (USAID), and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg, and will be available for supplies to low-andmiddle-income countries (LMIC).

Commenting on the USFDA tentative approval, Mr. Naresh Gupta, President, API Plus, Lupin said "I am delighted that we have received FDA's tentative approval for TLD. It is a significant approval for Lupin which has recently forayed into HIV business arena. We have a deep commitment to increasing access to quality and affordable treatment options for low-and-middle-income countries for decades. Being integrated with in-house manufacture of APIs and formulations gives us an opportunity to provide quality products and uninterrupted supplies for affordable access for patients in these countries."

Shares of LUPIN LTD. was last trading in BSE at Rs.1148.75 as compared to the previous close of Rs. 1161. The total number of shares traded during the day was 37432 in over 1815 trades.

The stock hit an intraday high of Rs. 1168.05 and intraday low of 1146.1. The net turnover during the day was Rs. 43253041.

Source : Equity Bulls

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